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Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00608205
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : September 19, 2013
Last Update Posted : October 21, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Head and Neck Cancer
Interventions: Drug: cisplatin
Drug: fluorouracil
Radiation: radiation therapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients recruited from Cleveland, Ohio medical clinics from December 2007 to August 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm A: Radiation With Concurrent Cisplatin Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B: Radiation With Concurrent 5-FU and Cisplatin Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Participant Flow:   Overall Study
    Arm A: Radiation With Concurrent Cisplatin   Arm B: Radiation With Concurrent 5-FU and Cisplatin
STARTED   35   34 
COMPLETED   32   31 
NOT COMPLETED   3   3 
Adverse Event                3                2 
Patient non-compliant                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm A: Radiation With Concurrent Cisplatin Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B: Radiation With Concurrent 5-FU and Cisplatin Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Total Total of all reporting groups

Baseline Measures
   Arm A: Radiation With Concurrent Cisplatin   Arm B: Radiation With Concurrent 5-FU and Cisplatin   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   34   69 
Age, Customized 
[Units: Participants]
     
40-49 years   6   10   16 
50-59 years   11   16   27 
60-69 years   17   6   23 
70-79 years   1   2   3 
Gender 
[Units: Participants]
     
Female   3   6   9 
Male   32   28   60 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   0   0   0 
Not Hispanic or Latino   35   34   69 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   1   1 
White   35   33   68 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   35   34   69 


  Outcome Measures

1.  Primary:   Relapse Free Survival   [ Time Frame: at 2 yrs from start of study ]

Measure Type Primary
Measure Title Relapse Free Survival
Measure Description Number of patients that are alive without recurrence when recurrence is defined by any subject with new evidence of cancer after achieving a complete response. Complete response is defined by the complete disappearance of all clinically and radiologically detectable tumor..
Time Frame at 2 yrs from start of study  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
intention to treat (ITT)

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   35   34 
Relapse Free Survival 
[Units: Participants]
 30   28 

No statistical analysis provided for Relapse Free Survival



2.  Secondary:   Patterns of Failure   [ Time Frame: 2 years from start of study ]

Measure Type Secondary
Measure Title Patterns of Failure
Measure Description Patients with any new evidence of cancer after achieving a complete response are considered to have recurrent disease. Biopsy verification will be obtained if at all possible and salvage surgery is recommended if possible. Disease recurrence will be characterized as either local, regional(nodal) or distant recurrence. Patients may have more than one kind of recurrence.
Time Frame 2 years from start of study  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
intention to treat (ITT)

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   35   34 
Patterns of Failure 
[Units: Participants]
   
Local recurrence   1   1 
Regional (nodal) recurrence   1   0 
Distant recurrence   4   4 

No statistical analysis provided for Patterns of Failure



3.  Secondary:   Overall Survival   [ Time Frame: 2 yrs from start of study ]

Measure Type Secondary
Measure Title Overall Survival
Measure Description Number of patients still alive from 2 years from start of study
Time Frame 2 yrs from start of study  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
intention to treat (ITT)

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   35   34 
Overall Survival 
[Units: Participants]
 34   29 

No statistical analysis provided for Overall Survival



4.  Secondary:   Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor   [ Time Frame: at 12 weeks after completing chemoradiotherapy ]

Measure Type Secondary
Measure Title Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor
Measure Description Twelve weeks after completing chemoradiotherapy, a formal evaluation for response will be made, to include a careful evaluation by the head and neck surgeon, medical and radiation oncologists, and, as appropriate, a radiologic and an endoscopic examination. Patients will be considered to have achieved either a clinical complete response (i.e. complete disappearance of all clinically and radiologically detectable tumor) or to have clinical persistent disease.
Time Frame at 12 weeks after completing chemoradiotherapy  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
intention to treat (ITT)

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   35   34 
Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor 
[Units: Participants]
 35   28 

No statistical analysis provided for Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor



5.  Secondary:   Number of Patients With a Pathological(Final)Complete Response   [ Time Frame: at 12 weeks after completing chemoradiotherapy and surgery ]

Measure Type Secondary
Measure Title Number of Patients With a Pathological(Final)Complete Response
Measure Description A Pathological, or final response will be assigned to subjects after any salvage surgery is performed for clinical persistent disease, and after planned neck dissection in those achieving a clinical complete response. If no surgery is performed after chemoradiotherapy, the clinical and pathological (final) response will be the same. Patient will be coded as having either a pathologic complete response, or as having pathologic persistent disease. A pathologic complete response will be defined as the total disappearance of all clinically and radiologically detectable tumor.
Time Frame at 12 weeks after completing chemoradiotherapy and surgery  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   35   34 
Number of Patients With a Pathological(Final)Complete Response 
[Units: Participants]
 35   31 

No statistical analysis provided for Number of Patients With a Pathological(Final)Complete Response



6.  Secondary:   Disease Recurrence   [ Time Frame: 2 years after start of study ]

Measure Type Secondary
Measure Title Disease Recurrence
Measure Description Number of patients with any new evidence of cancer after achieving a complete response (at 12 weeks after completing chemoradiotherapy) are considered to have recurrent disease.
Time Frame 2 years after start of study  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients that had a complete response after 12 weeks of therapy

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   35   31 
Disease Recurrence 
[Units: Participants]
 5   2 

No statistical analysis provided for Disease Recurrence



7.  Secondary:   Number of Patients That Required a Feeding Tube   [ Time Frame: 12 weeks (after treatment) ]

Measure Type Secondary
Measure Title Number of Patients That Required a Feeding Tube
Measure Description No text entered.
Time Frame 12 weeks (after treatment)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   29   26 
Number of Patients That Required a Feeding Tube 
[Units: Participants]
 0   3 

No statistical analysis provided for Number of Patients That Required a Feeding Tube



8.  Secondary:   Number of Patients That Required a Feeding Tube   [ Time Frame: 8 months after start of treatment ]

Measure Type Secondary
Measure Title Number of Patients That Required a Feeding Tube
Measure Description No text entered.
Time Frame 8 months after start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   28   24 
Number of Patients That Required a Feeding Tube 
[Units: Participants]
 0   0 

No statistical analysis provided for Number of Patients That Required a Feeding Tube



9.  Secondary:   Number of Patients That Required a Feeding Tube   [ Time Frame: 12 months after start of treatment ]

Measure Type Secondary
Measure Title Number of Patients That Required a Feeding Tube
Measure Description No text entered.
Time Frame 12 months after start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   28   23 
Number of Patients That Required a Feeding Tube 
[Units: Participants]
 0   0 

No statistical analysis provided for Number of Patients That Required a Feeding Tube



10.  Secondary:   Number of Patients That Required a Feeding Tube   [ Time Frame: 24 months after start of treatment ]

Measure Type Secondary
Measure Title Number of Patients That Required a Feeding Tube
Measure Description No text entered.
Time Frame 24 months after start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   21   17 
Number of Patients That Required a Feeding Tube 
[Units: Participants]
 0   0 

No statistical analysis provided for Number of Patients That Required a Feeding Tube



11.  Secondary:   Nausea Level   [ Time Frame: 12 weeks (after treatment) ]

Measure Type Secondary
Measure Title Nausea Level
Measure Description

Quality of life questionnaire asking "I have nausea".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4).

N (number of patients analyzed) is based on number of patients who completed the question.

Time Frame 12 weeks (after treatment)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   28   26 
Nausea Level 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.07  (0.26)   0.12  (0.33) 

No statistical analysis provided for Nausea Level



12.  Secondary:   Nausea Level   [ Time Frame: 8 months from start of treatment ]

Measure Type Secondary
Measure Title Nausea Level
Measure Description

Quality of life questionnaire asking "I have nausea".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 8 months from start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   27   23 
Nausea Level 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.15  (0.46)   0.09  (0.29) 

No statistical analysis provided for Nausea Level



13.  Secondary:   Nausea Level   [ Time Frame: 12 months from start of treatment ]

Measure Type Secondary
Measure Title Nausea Level
Measure Description

Quality of life questionnaire asking "I have nausea".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 12 months from start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   28   23 
Nausea Level 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.14  (0.45)   0.04  (0.21) 

No statistical analysis provided for Nausea Level



14.  Secondary:   Nausea Level   [ Time Frame: 24 months from start of treatment ]

Measure Type Secondary
Measure Title Nausea Level
Measure Description Quality of life questionnaire asking "I have nausea".
Time Frame 24 months from start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Radiation With Concurrent Cisplatin Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Radiation With Concurrent 5-FU and Cisplatin Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Radiation With Concurrent Cisplatin   Radiation With Concurrent 5-FU and Cisplatin 
Participants Analyzed   21   16 
Nausea Level 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.10  (0.3)   0  (0) 

No statistical analysis provided for Nausea Level



15.  Secondary:   Dry Mouth   [ Time Frame: 12 weeks (after treatment) ]

Measure Type Secondary
Measure Title Dry Mouth
Measure Description

Quality of life questionnaire asking "My mouth is dry".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 12 weeks (after treatment)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   27   25 
Dry Mouth 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.33  (0.83)   3.08  (1.15) 

No statistical analysis provided for Dry Mouth



16.  Secondary:   Dry Mouth   [ Time Frame: 8 months from start of treatment ]

Measure Type Secondary
Measure Title Dry Mouth
Measure Description

Quality of life questionnaire asking "My mouth is dry".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 8 months from start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   27   23 
Dry Mouth 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.67  (1.07)   3.09  (0.85) 

No statistical analysis provided for Dry Mouth



17.  Secondary:   Dry Mouth   [ Time Frame: 12 months from start of treatment ]

Measure Type Secondary
Measure Title Dry Mouth
Measure Description

Quality of life questionnaire asking "My mouth is dry".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 12 months from start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   27   22 
Dry Mouth 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.70  (1.03)   3.09  (0.92) 

No statistical analysis provided for Dry Mouth



18.  Secondary:   Dry Mouth   [ Time Frame: 24 months from start of treatment ]

Measure Type Secondary
Measure Title Dry Mouth
Measure Description

Quality of life questionnaire asking "My mouth is dry".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 24 months from start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   20   16 
Dry Mouth 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.60  (1.10)   2.94  (1.29) 

No statistical analysis provided for Dry Mouth



19.  Secondary:   Pain   [ Time Frame: 12 weeks (after treatment) ]

Measure Type Secondary
Measure Title Pain
Measure Description

Quality of life questionnaire asking "I have pain in my mouth, throat or neck".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 12 weeks (after treatment)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   29   26 
Pain 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.24  (1.06)   1.42  (0.95) 

No statistical analysis provided for Pain



20.  Secondary:   Pain   [ Time Frame: 8 months from start of treatment ]

Measure Type Secondary
Measure Title Pain
Measure Description

Quality of life questionnaire asking "I have pain in my mouth, throat or neck".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 8 months from start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   26   23 
Pain 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.65  (0.80)   0.74  (0.81) 

No statistical analysis provided for Pain



21.  Secondary:   Pain   [ Time Frame: 12 months from start of treatment ]

Measure Type Secondary
Measure Title Pain
Measure Description

Quality of life questionnaire asking "I have pain in my mouth, throat or neck".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 12 months from start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   28   23 
Pain 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.57  (0.74)   0.57  (0.79) 

No statistical analysis provided for Pain



22.  Secondary:   Pain   [ Time Frame: 24 months from start of treatment ]

Measure Type Secondary
Measure Title Pain
Measure Description

Quality of life questionnaire asking "I have pain in my mouth, throat or neck".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 24 months from start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   20   16 
Pain 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.60  (0.75)   0.75  (1.00) 

No statistical analysis provided for Pain



23.  Secondary:   Quality of Life   [ Time Frame: 12 weeks (after treatment) ]

Measure Type Secondary
Measure Title Quality of Life
Measure Description

Quality of life questionnaire asking "I am content with the quality of my life right now".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 12 weeks (after treatment)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   27   25 
Quality of Life 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.37  (1.08)   1.68  (1.14) 

No statistical analysis provided for Quality of Life



24.  Secondary:   Quality of Life   [ Time Frame: 8 months from start of treatment ]

Measure Type Secondary
Measure Title Quality of Life
Measure Description

Quality of life questionnaire asking "I am content with the quality of my life right now".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 8 months from start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   27   23 
Quality of Life 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.85  (1.13)   1.13  (1.18) 

No statistical analysis provided for Quality of Life



25.  Secondary:   Quality of Life   [ Time Frame: 12 months from start of treatment ]

Measure Type Secondary
Measure Title Quality of Life
Measure Description

Quality of life questionnaire asking "I am content with the quality of my life right now".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 12 months from start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   27   22 
Quality of Life 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.67  (1.00)   0.95  (0.84) 

No statistical analysis provided for Quality of Life



26.  Secondary:   Quality of Life   [ Time Frame: 24 months from start of treatment ]

Measure Type Secondary
Measure Title Quality of Life
Measure Description

Quality of life questionnaire asking "I am content with the quality of my life right now".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 24 months from start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   21   16 
Quality of Life 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.62  (0.86)   0.88  (0.81) 

No statistical analysis provided for Quality of Life



27.  Secondary:   Eating   [ Time Frame: 12 weeks (after treatment) ]

Measure Type Secondary
Measure Title Eating
Measure Description

Quality of life questionnaire asking "I am able to eat the foods i like".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 12 weeks (after treatment)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   27   25 
Eating 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.33  (1.07)   2.28  (1.02) 

No statistical analysis provided for Eating



28.  Secondary:   Eating   [ Time Frame: 8 months from start of treatment ]

Measure Type Secondary
Measure Title Eating
Measure Description

Quality of life questionnaire asking "I am able to eat the foods i like".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 8 months from start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   27   23 
Eating 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.93  (1.17)   1.78  (0.95) 

No statistical analysis provided for Eating



29.  Secondary:   Eating   [ Time Frame: 12 months from start of treatment ]

Measure Type Secondary
Measure Title Eating
Measure Description

Quality of life questionnaire asking "I am able to eat the foods i like".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 12 months from start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   27   21 
Eating 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.56  (1.25)   1.24  (1.09) 

No statistical analysis provided for Eating



30.  Secondary:   Eating   [ Time Frame: 24 months from start of treatment ]

Measure Type Secondary
Measure Title Eating
Measure Description

Quality of life questionnaire asking "I am able to eat the foods i like".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 24 months from start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   21   16 
Eating 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.52  (1.17)   1.13  (1.09) 

No statistical analysis provided for Eating



31.  Secondary:   Swallowing   [ Time Frame: 12 weeks (after treatment) ]

Measure Type Secondary
Measure Title Swallowing
Measure Description

Quality of life questionnaire asking "I can swallow naturally and easily".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 12 weeks (after treatment)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   29   26 
Swallowing 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.93  (1.07)   2.31  (0.97) 

No statistical analysis provided for Swallowing



32.  Secondary:   Swallowing   [ Time Frame: 8 months after start of treatment ]

Measure Type Secondary
Measure Title Swallowing
Measure Description

Quality of life questionnaire asking "I can swallow naturally and easily".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 8 months after start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   26   23 
Swallowing 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.31  (1.12)   1.83  (1.03) 

No statistical analysis provided for Swallowing



33.  Secondary:   Swallowing   [ Time Frame: 12 months after start of treatment ]

Measure Type Secondary
Measure Title Swallowing
Measure Description

Quality of life questionnaire asking "I can swallow naturally and easily".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 12 months after start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   28   23 
Swallowing 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.61  (1.13)   1.52  (1.16) 

No statistical analysis provided for Swallowing



34.  Secondary:   Swallowing   [ Time Frame: 24 months after start of treatment ]

Measure Type Secondary
Measure Title Swallowing
Measure Description

Quality of life questionnaire asking "I can swallow naturally and easily".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 24 months after start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   20   16 
Swallowing 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.45  (1.00)   1.63  (1.20) 

No statistical analysis provided for Swallowing



35.  Secondary:   Alcohol Consumption   [ Time Frame: 12 weeks (after treatment) ]

Measure Type Secondary
Measure Title Alcohol Consumption
Measure Description

Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 12 weeks (after treatment)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   29   26 
Alcohol Consumption 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.28  (0.65)   3.27  (0.87) 

No statistical analysis provided for Alcohol Consumption



36.  Secondary:   Alcohol Consumption   [ Time Frame: 8 months after start of treatment ]

Measure Type Secondary
Measure Title Alcohol Consumption
Measure Description

Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 8 months after start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   25   23 
Alcohol Consumption 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.96  (0.89)   3.00  (0.85) 

No statistical analysis provided for Alcohol Consumption



37.  Secondary:   Alcohol Consumption   [ Time Frame: 12 months after start of treatment ]

Measure Type Secondary
Measure Title Alcohol Consumption
Measure Description

Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 12 months after start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   27   23 
Alcohol Consumption 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.85  (0.72)   2.91  (0.73) 

No statistical analysis provided for Alcohol Consumption



38.  Secondary:   Alcohol Consumption   [ Time Frame: 24 months after start of treatment ]

Measure Type Secondary
Measure Title Alcohol Consumption
Measure Description

Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 24 months after start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   20   16 
Alcohol Consumption 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.85  (0.88)   2.81  (0.66) 

No statistical analysis provided for Alcohol Consumption



39.  Secondary:   Solid Foods   [ Time Frame: 12 weeks (after treatment) ]

Measure Type Secondary
Measure Title Solid Foods
Measure Description

Quality of life questionnaire asking "I can eat solid foods".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 12 weeks (after treatment)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   29   26 
Solid Foods 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.41  (1.35)   1.73  (1.15) 

No statistical analysis provided for Solid Foods



40.  Secondary:   Solid Foods   [ Time Frame: 8 months after start of treatment ]

Measure Type Secondary
Measure Title Solid Foods
Measure Description

Quality of life questionnaire asking "I can eat solid foods".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 8 months after start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   26   23 
Solid Foods 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.96  (1.15)   1.13  (1.06) 

No statistical analysis provided for Solid Foods



41.  Secondary:   Solid Foods   [ Time Frame: 12 months after start of treatment ]

Measure Type Secondary
Measure Title Solid Foods
Measure Description

Quality of life questionnaire asking "I can eat solid foods".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 12 months after start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   27   23 
Solid Foods 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.78  (0.97)   0.70  (0.93) 

No statistical analysis provided for Solid Foods



42.  Secondary:   Solid Foods   [ Time Frame: 24 months after start of treatment ]

Measure Type Secondary
Measure Title Solid Foods
Measure Description

Quality of life questionnaire asking "I can eat solid foods".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame 24 months after start of treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Reporting Groups
  Description
Arm A Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Arm B Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Measured Values
   Arm A   Arm B 
Participants Analyzed   20   16 
Solid Foods 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.85  (0.93)   0.56  (0.89) 

No statistical analysis provided for Solid Foods




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. David Adelstein
Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
phone: 216-444-9310
e-mail: adelstd@ccf.org



Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00608205     History of Changes
Other Study ID Numbers: CASE3307
P30CA043703 ( U.S. NIH Grant/Contract )
NCI-2010-01197 ( Other Identifier: NCI/CTRP )
First Submitted: January 30, 2008
First Posted: February 6, 2008
Results First Submitted: July 11, 2013
Results First Posted: September 19, 2013
Last Update Posted: October 21, 2016