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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Enrollment 69
Recruitment Details Patients recruited from Cleveland, Ohio medical clinics from December 2007 to August 2012.
Pre-assignment Details  
Arm/Group Title Arm A: Radiation With Concurrent Cisplatin Arm B: Radiation With Concurrent 5-FU and Cisplatin
Hide Arm/Group Description 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. Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Period Title: Overall Study
Started 35 34
Completed 32 31
Not Completed 3 3
Reason Not Completed
Adverse Event             3             2
Patient non-compliant             0             1
Arm/Group Title Arm A: Radiation With Concurrent Cisplatin Arm B: Radiation With Concurrent 5-FU and Cisplatin Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 35 34 69
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 34 participants 69 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
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 34 participants 69 participants
Female
3
   8.6%
6
  17.6%
9
  13.0%
Male
32
  91.4%
28
  82.4%
60
  87.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 34 participants 69 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
35
 100.0%
34
 100.0%
69
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 34 participants 69 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   2.9%
1
   1.4%
White
35
 100.0%
33
  97.1%
68
  98.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants 34 participants 69 participants
35 34 69
1.Primary Outcome
Title Relapse Free Survival
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
intention to treat (ITT)
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 35 34
Measure Type: Number
Unit of Measure: participants
30 28
2.Secondary Outcome
Title Patterns of Failure
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
intention to treat (ITT)
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 35 34
Measure Type: Number
Unit of Measure: participants
Local recurrence 1 1
Regional (nodal) recurrence 1 0
Distant recurrence 4 4
3.Secondary Outcome
Title Overall Survival
Hide Description Number of patients still alive from 2 years from start of study
Time Frame 2 yrs from start of study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
intention to treat (ITT)
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 35 34
Measure Type: Number
Unit of Measure: participants
34 29
4.Secondary Outcome
Title Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
intention to treat (ITT)
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 35 34
Measure Type: Number
Unit of Measure: participants
35 28
5.Secondary Outcome
Title Number of Patients With a Pathological(Final)Complete Response
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 35 34
Measure Type: Number
Unit of Measure: participants
35 31
6.Secondary Outcome
Title Disease Recurrence
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients that had a complete response after 12 weeks of therapy
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 35 31
Measure Type: Number
Unit of Measure: participants
5 2
7.Secondary Outcome
Title Number of Patients That Required a Feeding Tube
Hide Description [Not Specified]
Time Frame 12 weeks (after treatment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 29 26
Measure Type: Number
Unit of Measure: participants
0 3
8.Secondary Outcome
Title Number of Patients That Required a Feeding Tube
Hide Description [Not Specified]
Time Frame 8 months after start of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 28 24
Measure Type: Number
Unit of Measure: participants
0 0
9.Secondary Outcome
Title Number of Patients That Required a Feeding Tube
Hide Description [Not Specified]
Time Frame 12 months after start of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 28 23
Measure Type: Number
Unit of Measure: participants
0 0
10.Secondary Outcome
Title Number of Patients That Required a Feeding Tube
Hide Description [Not Specified]
Time Frame 24 months after start of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 21 17
Measure Type: Number
Unit of Measure: participants
0 0
11.Secondary Outcome
Title Nausea Level
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 28 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.07  (0.26) 0.12  (0.33)
12.Secondary Outcome
Title Nausea Level
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 27 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.15  (0.46) 0.09  (0.29)
13.Secondary Outcome
Title Nausea Level
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 28 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.14  (0.45) 0.04  (0.21)
14.Secondary Outcome
Title Nausea Level
Hide Description Quality of life questionnaire asking "I have nausea".
Time Frame 24 months from start of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Radiation With Concurrent Cisplatin Radiation With Concurrent 5-FU and Cisplatin
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 21 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.10  (0.3) 0  (0)
15.Secondary Outcome
Title Dry Mouth
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.33  (0.83) 3.08  (1.15)
16.Secondary Outcome
Title Dry Mouth
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 27 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.67  (1.07) 3.09  (0.85)
17.Secondary Outcome
Title Dry Mouth
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 27 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.70  (1.03) 3.09  (0.92)
18.Secondary Outcome
Title Dry Mouth
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 20 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.60  (1.10) 2.94  (1.29)
19.Secondary Outcome
Title Pain
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 29 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.24  (1.06) 1.42  (0.95)
20.Secondary Outcome
Title Pain
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 26 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.65  (0.80) 0.74  (0.81)
21.Secondary Outcome
Title Pain
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 28 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.57  (0.74) 0.57  (0.79)
22.Secondary Outcome
Title Pain
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 20 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.60  (0.75) 0.75  (1.00)
23.Secondary Outcome
Title Quality of Life
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.37  (1.08) 1.68  (1.14)
24.Secondary Outcome
Title Quality of Life
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 27 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.85  (1.13) 1.13  (1.18)
25.Secondary Outcome
Title Quality of Life
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 27 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.67  (1.00) 0.95  (0.84)
26.Secondary Outcome
Title Quality of Life
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 21 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.62  (0.86) 0.88  (0.81)
27.Secondary Outcome
Title Eating
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.33  (1.07) 2.28  (1.02)
28.Secondary Outcome
Title Eating
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 27 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.93  (1.17) 1.78  (0.95)
29.Secondary Outcome
Title Eating
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 27 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.56  (1.25) 1.24  (1.09)
30.Secondary Outcome
Title Eating
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 21 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.52  (1.17) 1.13  (1.09)
31.Secondary Outcome
Title Swallowing
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 29 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.93  (1.07) 2.31  (0.97)
32.Secondary Outcome
Title Swallowing
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 26 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.31  (1.12) 1.83  (1.03)
33.Secondary Outcome
Title Swallowing
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 28 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.61  (1.13) 1.52  (1.16)
34.Secondary Outcome
Title Swallowing
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 20 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.45  (1.00) 1.63  (1.20)
35.Secondary Outcome
Title Alcohol Consumption
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 29 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.28  (0.65) 3.27  (0.87)
36.Secondary Outcome
Title Alcohol Consumption
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 25 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.96  (0.89) 3.00  (0.85)
37.Secondary Outcome
Title Alcohol Consumption
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 27 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.85  (0.72) 2.91  (0.73)
38.Secondary Outcome
Title Alcohol Consumption
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 20 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.85  (0.88) 2.81  (0.66)
39.Secondary Outcome
Title Solid Foods
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 29 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.41  (1.35) 1.73  (1.15)
40.Secondary Outcome
Title Solid Foods
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 26 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.96  (1.15) 1.13  (1.06)
41.Secondary Outcome
Title Solid Foods
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 27 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.78  (0.97) 0.70  (0.93)
42.Secondary Outcome
Title Solid Foods
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
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.
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Overall Number of Participants Analyzed 20 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.85  (0.93) 0.56  (0.89)
Time Frame Adverse event data was collected over a 2 year period from study start.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A: Radiation With Concurrent Cisplatin Arm B: Radiation With Concurrent 5-FU and Cisplatin
Hide Arm/Group Description 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. Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
All-Cause Mortality
Arm A: Radiation With Concurrent Cisplatin Arm B: Radiation With Concurrent 5-FU and Cisplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A: Radiation With Concurrent Cisplatin Arm B: Radiation With Concurrent 5-FU and Cisplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   7/35 (20.00%)   14/34 (41.18%) 
Blood and lymphatic system disorders     
Anemia * 1  0/35 (0.00%)  1/34 (2.94%) 
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 1  2/35 (5.71%)  9/34 (26.47%) 
Neutropenia * 1  0/35 (0.00%)  1/34 (2.94%) 
Cardiac disorders     
Cardiac * 1  0/35 (0.00%)  2/34 (5.88%) 
Gastrointestinal disorders     
Diarrhea * 1  1/35 (2.86%)  0/34 (0.00%) 
Malnutrition * 1  1/35 (2.86%)  2/34 (5.88%) 
Mucositis/Dysphagia * 1  0/35 (0.00%)  1/34 (2.94%) 
Nausea/Vomiting * 1  1/35 (2.86%)  3/34 (8.82%) 
General disorders     
Pain-not otherwise specified (NOS) * 1  1/35 (2.86%)  0/34 (0.00%) 
Infections and infestations     
Pneumonia * 1  1/35 (2.86%)  2/34 (5.88%) 
Injury, poisoning and procedural complications     
Fracture * 1  0/35 (0.00%)  1/34 (2.94%) 
Investigations     
Hypokalemia * 1  0/35 (0.00%)  1/34 (2.94%) 
Metabolism and nutrition disorders     
Anorexia * 1  0/35 (0.00%)  1/34 (2.94%) 
Dehydration * 1  2/35 (5.71%)  3/34 (8.82%) 
Hypoalbuminemia * 1  0/35 (0.00%)  1/34 (2.94%) 
Hypocalcemia * 1  0/35 (0.00%)  1/34 (2.94%) 
Musculoskeletal and connective tissue disorders     
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower * 1  0/35 (0.00%)  1/34 (2.94%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pain - Tumor pain * 1  0/35 (0.00%)  1/34 (2.94%) 
Nervous system disorders     
Cranial Neuropathy/ Hearing and Balance * 1  3/35 (8.57%)  0/34 (0.00%) 
Dizziness * 1  0/35 (0.00%)  1/34 (2.94%) 
Renal and urinary disorders     
Renal Insufficiency * 1  1/35 (2.86%)  0/34 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration * 1  0/35 (0.00%)  1/34 (2.94%) 
Vascular disorders     
Thrombosis/embolism * 1  2/35 (5.71%)  3/34 (8.82%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A: Radiation With Concurrent Cisplatin Arm B: Radiation With Concurrent 5-FU and Cisplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   35/35 (100.00%)   34/34 (100.00%) 
Blood and lymphatic system disorders     
Neutropenia * 1  12/35 (34.29%)  21/34 (61.76%) 
Thrombocytopenia * 1  10/35 (28.57%)  14/34 (41.18%) 
Endocrine disorders     
Hypothyroidism * 1  14/35 (40.00%)  16/34 (47.06%) 
Gastrointestinal disorders     
Dysphagia (difficulty swallowing) * 1  33/35 (94.29%)  34/34 (100.00%) 
Mucositis * 1  34/35 (97.14%)  33/34 (97.06%) 
Mucositis/Dysphagia * 1  34/35 (97.14%)  34/34 (100.00%) 
Nausea/Vomiting * 1  27/35 (77.14%)  23/34 (67.65%) 
Stomatitis * 1  13/35 (37.14%)  18/34 (52.94%) 
Injury, poisoning and procedural complications     
Skin Toxicity from Radiation * 1  33/35 (94.29%)  30/34 (88.24%) 
Investigations     
Increased Creatinine * 1  9/35 (25.71%)  1/34 (2.94%) 
Nervous system disorders     
Cranial Neuropathy/ Hearing and Balance * 1  1/35 (2.86%)  0/34 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
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