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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 ]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


  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