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

• Sponsor: Case Comprehensive Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00608205
• Collaborator: (none)
• Enrollment: 69
• Locations: 2
• Arms: 2
• Duration (Months): 103
• Patients Per Site: 34.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin and fluorouracil may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without fluorouracil in treating patients with head and neck cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy and cisplatin to compare how well they work with or without fluorouracil in treating patients with stage III or stage IV head and neck cancer.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: cisplatin; Drug: fluorouracil; Radiation: radiation therapy	Phase 3

Detailed Description

OBJECTIVES:

• To compare the relapse-free survival of patients treated with radiotherapy and cisplatin with vs without fluorouracil.

• To compare the overall survival, local control without surgery, and patterns of failure in patients treated with these regimens.

• To compare the acute and long-term toxicity of these regimens in these patients.

• To compare the quality of life of patients treated with these regimens.

• To prospectively collect biopsy material, mucosal scrapings, and serum in an effort to generate hypotheses for future correlative studies.

OUTLINE: This is a multicenter study. Patients are stratified according to radiotherapy schedule (once daily vs twice daily) and radiotherapy planning (2D vs 3D vs intensity-modulated radiotherapy). Patients are randomized to 1 of 2 treatment arms.

• Arm I: 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 II: Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Patients with biopsy-verified residual disease at the primary site or local recurrence after achieving a complete response to chemoradiotherapy may undergo salvage surgery 12 weeks after the completion of chemoradiotherapy.

Patients complete questionnaires periodically to assess late toxicity and quality of life.

After completion of study treatment, patients are followed periodically.

Study Design

• Study Type: Interventional
• Actual Enrollment: 69 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III Randomized Trial Comparing Single Agent Cisplatin With the Combination of 5-Fluorouracil and Cisplatin, Concurrent With Radiation Therapy in Stage III and IV Squamous Cell Head and Neck Cancer
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: cisplatin; Given IV; Other Names: CDDP ; Radiation: radiation therapy; Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks; Other Names: radiation
Experimental: 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.	Drug: cisplatin; Given IV; Other Names: CDDP ; Drug: fluorouracil; Given IV; Radiation: radiation therapy; Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks; Other Names: radiation

Outcome Measures

Primary Outcome Measures

1. Relapse Free Survival [at 2 yrs from start of study]

   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..

Secondary Outcome Measures

1. Patterns of Failure [2 years from start of study]

   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.

2. Overall Survival [2 yrs from start of study]

   Number of patients still alive from 2 years from start of study

3. Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor [at 12 weeks after completing chemoradiotherapy]

   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.

4. Number of Patients With a Pathological(Final)Complete Response [at 12 weeks after completing chemoradiotherapy and surgery]

   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.

5. Disease Recurrence [2 years after start of study]

   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.

6. Number of Patients That Required a Feeding Tube [12 weeks (after treatment)]

7. Number of Patients That Required a Feeding Tube [8 months after start of treatment]

8. Number of Patients That Required a Feeding Tube [12 months after start of treatment]

9. Number of Patients That Required a Feeding Tube [24 months after start of treatment]

10. Nausea Level [12 weeks (after treatment)]

    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.

11. Nausea Level [8 months from start of treatment]

    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.

12. Nausea Level [12 months from start of treatment]

    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.

13. Nausea Level [24 months from start of treatment]

    Quality of life questionnaire asking "I have nausea".

14. Dry Mouth [12 weeks (after treatment)]

    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.

15. Dry Mouth [8 months from start of treatment]

    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.

16. Dry Mouth [12 months from start of treatment]

    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.

17. Dry Mouth [24 months from start of treatment]

    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.

18. Pain [12 weeks (after treatment)]

    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.

19. Pain [8 months from start of treatment]

    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.

20. Pain [12 months from start of treatment]

    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.

21. Pain [24 months from start of treatment]

    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.

22. Quality of Life [12 weeks (after treatment)]

    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.

23. Quality of Life [8 months from start of treatment]

    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.

24. Quality of Life [12 months from start of treatment]

    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.

25. Quality of Life [24 months from start of treatment]

    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.

26. Eating [12 weeks (after treatment)]

    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.

27. Eating [8 months from start of treatment]

    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.

28. Eating [12 months from start of treatment]

    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.

29. Eating [24 months from start of treatment]

    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.

30. Swallowing [12 weeks (after treatment)]

    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.

31. Swallowing [8 months after start of treatment]

    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.

32. Swallowing [12 months after start of treatment]

    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.

33. Swallowing [24 months after start of treatment]

    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.

34. Alcohol Consumption [12 weeks (after treatment)]

    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.

35. Alcohol Consumption [8 months after start of treatment]

    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.

36. Alcohol Consumption [12 months after start of treatment]

    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.

37. Alcohol Consumption [24 months after start of treatment]

    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.

38. Solid Foods [12 weeks (after treatment)]

    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.

39. Solid Foods [8 months after start of treatment]

    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.

40. Solid Foods [12 months after start of treatment]

    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.

41. Solid Foods [24 months after start of treatment]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx

• No histologic diagnosis other than squamous cell carcinoma

• A primary site must be identified

• Must have locoregionally confined stage III (excluding T1-2, N1) or stage IV disease

• No evidence of nodal disease below the clavicles or distant hematogenous metastases (M0)

• No stage IVC disease (stage IVB disease allowed)

• Deemed appropriate for definitive non-operative management with curative intent

• Resectable disease is not required

• No primary cancer of the nasopharynx, paranasal sinus, or salivary gland

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• WBC > 3,500/mm³

• Platelet count > 100,000/mm³

• Serum creatinine < 2.0 mg/dL

• Alkaline phosphatase < 2 times normal

• AST < 2 times normal

• Bilirubin ≤ 2.0 mg/dL

• Serum calcium normal

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No unstable or uncontrolled angina

• No clinically apparent jaundice

• No active infection

• No history of any other malignancy (except squamous cell or basal cell skin cancer or cervical carcinoma in situ), unless the patient has been continuously disease-free for at least 5 years

• Not a poor compliance risk

• Able to withstand the rigors of intensive treatment

• Available for and compliant with adequate long-term follow-up

PRIOR CONCURRENT THERAPY:

• No prior definitive surgery or radiotherapy for this malignancy

• No prior chemotherapy, immunotherapy, or epidermal growth factor receptor inhibitors for any disease Patients who have had previous definitive surgery, or radiation therapy for this malignancy, and patients who have had any previous chemotherapy, immunotherapy, or EGF receptor inhibition for any disease are ineligible.

Exclusion Criteria Patients with primary cancers of the nasopharynx, paranasal sinus or salivary gland are ineligible.

Patients with unstable or uncontrolled angina, clinically apparent jaundice, or active infection are ineligible.

Patients with a history of any other malignancy (except squamous or basal cell skin cancer or cervical carcinoma in-situ) are ineligible, unless the patient has been continuously disease-free for at least 5 years.

Patients with any histologic diagnosis other than squamous cell carcinoma are ineligible.

Patients who might be a poor-compliance risk are ineligible.

Pregnant or breastfeeding women are ineligible. Women/men of reproductive potential must be willing to practice acceptable methods of birth control to prevent pregnancy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5065
2	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• Case Comprehensive Cancer Center

Investigators

• Principal Investigator: David J. Adelstein, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
• Principal Investigator: Panayiotis Savvides, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT00608205
• Other Study ID Numbers: CASE3307; NCI-2010-01197
• First Posted: Feb 6, 2008
• Last Update Posted: Aug 6, 2020
• Last Verified: Jul 1, 2020

• Keywords provided by Case Comprehensive Cancer Center: stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the larynx
• Additional relevant MeSH terms: Head and Neck Neoplasms; Fluorouracil

Study Results

Participant Flow

Recruitment Details	Patients recruited from Cleveland, Ohio medical clinics from December 2007 to August 2012.

Arm/Group Title	Arm A: Radiation With Concurrent Cisplatin	Arm B: Radiation With Concurrent 5-FU and Cisplatin
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

Baseline Characteristics

Arm/Group Title	Arm A: Radiation With Concurrent Cisplatin	Arm B: Radiation With Concurrent 5-FU and Cisplatin	Total
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 Participants	35	34	69
Age, Customized (participants) [Number]
40-49 years	6 17.1%	10 29.4%	16 23.2%
50-59 years	11 31.4%	16 47.1%	27 39.1%
60-69 years	17 48.6%	6 17.6%	23 33.3%
70-79 years	1 2.9%	2 5.9%	3 4.3%
Sex: Female, Male (Count of Participants)
Female	3 8.6%	6 17.6%	9 13%
Male	32 91.4%	28 82.4%	60 87%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	35 100%	34 100%	69 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	1 2.9%	1 1.4%
White	35 100%	33 97.1%	68 98.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	35 100%	34 100%	69 100%

Outcome Measures

1. Primary Outcome

Title	Relapse Free Survival
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

Outcome Measure Data

Analysis Population Description

intention to treat (ITT)

Arm/Group Title	Arm A	Arm B
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.
Measure Participants	35	34
Number [participants]	30 85.7%	28 82.4%

2. Secondary Outcome

Title	Patterns of Failure
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

Outcome Measure Data

Analysis Population Description

intention to treat (ITT)

Arm/Group Title	Arm A	Arm B
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.
Measure Participants	35	34
Local recurrence	1 2.9%	1 2.9%
Regional (nodal) recurrence	1 2.9%	0 0%
Distant recurrence	4 11.4%	4 11.8%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

intention to treat (ITT)

Arm/Group Title	Arm A	Arm B
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.
Measure Participants	35	34
Number [participants]	34 97.1%	29 85.3%

4. Secondary Outcome

Title	Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor
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

Outcome Measure Data

Analysis Population Description

intention to treat (ITT)

Arm/Group Title	Arm A	Arm B
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.
Measure Participants	35	34
Number [participants]	35 100%	28 82.4%

5. Secondary Outcome

Title	Number of Patients With a Pathological(Final)Complete Response
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A	Arm B
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.
Measure Participants	35	34
Number [participants]	35 100%	31 91.2%

6. Secondary Outcome

Title	Disease Recurrence
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

Outcome Measure Data

Analysis Population Description

Patients that had a complete response after 12 weeks of therapy

Arm/Group Title	Arm A	Arm B
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.
Measure Participants	35	31
Number [participants]	5 14.3%	2 5.9%

7. Secondary Outcome

Title	Number of Patients That Required a Feeding Tube
Time Frame	12 weeks (after treatment)

Outcome Measure Data

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
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.
Measure Participants	29	26
Number [participants]	0 0%	3 8.8%

8. Secondary Outcome

Title	Number of Patients That Required a Feeding Tube
Time Frame	8 months after start of treatment

Outcome Measure Data

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
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.
Measure Participants	28	24
Number [participants]	0 0%	0 0%

9. Secondary Outcome

Title	Number of Patients That Required a Feeding Tube
Time Frame	12 months after start of treatment

Outcome Measure Data

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
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.
Measure Participants	28	23
Number [participants]	0 0%	0 0%

10. Secondary Outcome

Title	Number of Patients That Required a Feeding Tube
Time Frame	24 months after start of treatment

Outcome Measure Data

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
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.
Measure Participants	21	17
Number [participants]	0 0%	0 0%

11. Secondary Outcome

Title	Nausea Level
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)

Outcome Measure Data

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
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.
Measure Participants	28	26
Mean (Standard Deviation) [units on a scale]	0.07 (0.26)	0.12 (0.33)

12. Secondary Outcome

Title	Nausea Level
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

Outcome Measure Data

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
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.
Measure Participants	27	23
Mean (Standard Deviation) [units on a scale]	0.15 (0.46)	0.09 (0.29)

13. Secondary Outcome

Title	Nausea Level
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

Outcome Measure Data

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
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.
Measure Participants	28	23
Mean (Standard Deviation) [units on a scale]	0.14 (0.45)	0.04 (0.21)

14. Secondary Outcome

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

Outcome Measure Data

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
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.
Measure Participants	21	16
Mean (Standard Deviation) [units on a scale]	0.10 (0.3)	0 (0)

15. Secondary Outcome

Title	Dry Mouth
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)

Outcome Measure Data

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
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.
Measure Participants	27	25
Mean (Standard Deviation) [units on a scale]	3.33 (0.83)	3.08 (1.15)

16. Secondary Outcome

Title	Dry Mouth
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

Outcome Measure Data

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
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.
Measure Participants	27	23
Mean (Standard Deviation) [units on a scale]	2.67 (1.07)	3.09 (0.85)

17. Secondary Outcome

Title	Dry Mouth
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

Outcome Measure Data

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
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.
Measure Participants	27	22
Mean (Standard Deviation) [units on a scale]	2.70 (1.03)	3.09 (0.92)

18. Secondary Outcome

Title	Dry Mouth
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

Outcome Measure Data

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
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.
Measure Participants	20	16
Mean (Standard Deviation) [units on a scale]	2.60 (1.10)	2.94 (1.29)

19. Secondary Outcome

Title	Pain
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)

Outcome Measure Data

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
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.
Measure Participants	29	26
Mean (Standard Deviation) [units on a scale]	1.24 (1.06)	1.42 (0.95)

20. Secondary Outcome

Title	Pain
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

Outcome Measure Data

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
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.
Measure Participants	26	23
Mean (Standard Deviation) [units on a scale]	0.65 (0.80)	0.74 (0.81)

21. Secondary Outcome

Title	Pain
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

Outcome Measure Data

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
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.
Measure Participants	28	23
Mean (Standard Deviation) [units on a scale]	0.57 (0.74)	0.57 (0.79)

22. Secondary Outcome

Title	Pain
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

Outcome Measure Data

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
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.
Measure Participants	20	16
Mean (Standard Deviation) [units on a scale]	0.60 (0.75)	0.75 (1.00)

23. Secondary Outcome

Title	Quality of Life
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)

Outcome Measure Data

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
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.
Measure Participants	27	25
Mean (Standard Deviation) [units on a scale]	1.37 (1.08)	1.68 (1.14)

24. Secondary Outcome

Title	Quality of Life
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

Outcome Measure Data

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
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.
Measure Participants	27	23
Mean (Standard Deviation) [units on a scale]	0.85 (1.13)	1.13 (1.18)

25. Secondary Outcome

Title	Quality of Life
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

Outcome Measure Data

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
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.
Measure Participants	27	22
Mean (Standard Deviation) [units on a scale]	0.67 (1.00)	0.95 (0.84)

26. Secondary Outcome

Title	Quality of Life
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

Outcome Measure Data

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
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.
Measure Participants	21	16
Mean (Standard Deviation) [units on a scale]	0.62 (0.86)	0.88 (0.81)

27. Secondary Outcome

Title	Eating
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)

Outcome Measure Data

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
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.
Measure Participants	27	25
Mean (Standard Deviation) [units on a scale]	2.33 (1.07)	2.28 (1.02)

28. Secondary Outcome

Title	Eating
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

Outcome Measure Data

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
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.
Measure Participants	27	23
Mean (Standard Deviation) [units on a scale]	1.93 (1.17)	1.78 (0.95)

29. Secondary Outcome

Title	Eating
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

Outcome Measure Data

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
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.
Measure Participants	27	21
Mean (Standard Deviation) [units on a scale]	1.56 (1.25)	1.24 (1.09)

30. Secondary Outcome

Title	Eating
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

Outcome Measure Data

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
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.
Measure Participants	21	16
Mean (Standard Deviation) [units on a scale]	1.52 (1.17)	1.13 (1.09)

31. Secondary Outcome

Title	Swallowing
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)

Outcome Measure Data

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
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.
Measure Participants	29	26
Mean (Standard Deviation) [units on a scale]	1.93 (1.07)	2.31 (0.97)

32. Secondary Outcome

Title	Swallowing
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

Outcome Measure Data

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
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.
Measure Participants	26	23
Mean (Standard Deviation) [units on a scale]	1.31 (1.12)	1.83 (1.03)

33. Secondary Outcome

Title	Swallowing
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

Outcome Measure Data

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
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.
Measure Participants	28	23
Mean (Standard Deviation) [units on a scale]	1.61 (1.13)	1.52 (1.16)

34. Secondary Outcome

Title	Swallowing
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

Outcome Measure Data

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
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.
Measure Participants	20	16
Mean (Standard Deviation) [units on a scale]	1.45 (1.00)	1.63 (1.20)

35. Secondary Outcome

Title	Alcohol Consumption
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)

Outcome Measure Data

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
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.
Measure Participants	29	26
Mean (Standard Deviation) [units on a scale]	3.28 (0.65)	3.27 (0.87)

36. Secondary Outcome

Title	Alcohol Consumption
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

Outcome Measure Data

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
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.
Measure Participants	25	23
Mean (Standard Deviation) [units on a scale]	2.96 (0.89)	3.00 (0.85)

37. Secondary Outcome

Title	Alcohol Consumption
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

Outcome Measure Data

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
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.
Measure Participants	27	23
Mean (Standard Deviation) [units on a scale]	2.85 (0.72)	2.91 (0.73)

38. Secondary Outcome

Title	Alcohol Consumption
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

Outcome Measure Data

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
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.
Measure Participants	20	16
Mean (Standard Deviation) [units on a scale]	2.85 (0.88)	2.81 (0.66)

39. Secondary Outcome

Title	Solid Foods
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)

Outcome Measure Data

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
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.
Measure Participants	29	26
Mean (Standard Deviation) [units on a scale]	1.41 (1.35)	1.73 (1.15)

40. Secondary Outcome

Title	Solid Foods
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

Outcome Measure Data

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
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.
Measure Participants	26	23
Mean (Standard Deviation) [units on a scale]	0.96 (1.15)	1.13 (1.06)

41. Secondary Outcome

Title	Solid Foods
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

Outcome Measure Data

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
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.
Measure Participants	27	23
Mean (Standard Deviation) [units on a scale]	0.78 (0.97)	0.70 (0.93)

42. Secondary Outcome

Title	Solid Foods
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

Outcome Measure Data

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
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.
Measure Participants	20	16
Mean (Standard Deviation) [units on a scale]	0.85 (0.93)	0.56 (0.89)

Adverse Events

Time Frame	Adverse event data was collected over a 2 year period from study start.
Arm/Group Title	Arm A: Radiation With Concurrent Cisplatin		Arm B: Radiation With Concurrent 5-FU and Cisplatin
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm A: Radiation With Concurrent Cisplatin		Arm B: Radiation With Concurrent 5-FU and Cisplatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/35 (20%)		14/34 (41.2%)
Blood and lymphatic system disorders
Anemia	0/35 (0%)		1/34 (2.9%)
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe	2/35 (5.7%)		9/34 (26.5%)
Neutropenia	0/35 (0%)		1/34 (2.9%)
Cardiac disorders
Cardiac	0/35 (0%)		2/34 (5.9%)
Gastrointestinal disorders
Diarrhea	1/35 (2.9%)		0/34 (0%)
Malnutrition	1/35 (2.9%)		2/34 (5.9%)
Mucositis/Dysphagia	0/35 (0%)		1/34 (2.9%)
Nausea/Vomiting	1/35 (2.9%)		3/34 (8.8%)
General disorders
Pain-not otherwise specified (NOS)	1/35 (2.9%)		0/34 (0%)
Infections and infestations
Pneumonia	1/35 (2.9%)		2/34 (5.9%)
Injury, poisoning and procedural complications
Fracture	0/35 (0%)		1/34 (2.9%)
Investigations
Hypokalemia	0/35 (0%)		1/34 (2.9%)
Metabolism and nutrition disorders
Anorexia	0/35 (0%)		1/34 (2.9%)
Dehydration	2/35 (5.7%)		3/34 (8.8%)
Hypoalbuminemia	0/35 (0%)		1/34 (2.9%)
Hypocalcemia	0/35 (0%)		1/34 (2.9%)
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower	0/35 (0%)		1/34 (2.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain - Tumor pain	0/35 (0%)		1/34 (2.9%)
Nervous system disorders
Cranial Neuropathy/ Hearing and Balance	3/35 (8.6%)		0/34 (0%)
Dizziness	0/35 (0%)		1/34 (2.9%)
Renal and urinary disorders
Renal Insufficiency	1/35 (2.9%)		0/34 (0%)
Respiratory, thoracic and mediastinal disorders
Aspiration	0/35 (0%)		1/34 (2.9%)
Vascular disorders
Thrombosis/embolism	2/35 (5.7%)		3/34 (8.8%)
Other (Not Including Serious) Adverse Events
	Arm A: Radiation With Concurrent Cisplatin		Arm B: Radiation With Concurrent 5-FU and Cisplatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	35/35 (100%)		34/34 (100%)
Blood and lymphatic system disorders
Neutropenia	12/35 (34.3%)		21/34 (61.8%)
Thrombocytopenia	10/35 (28.6%)		14/34 (41.2%)
Endocrine disorders
Hypothyroidism	14/35 (40%)		16/34 (47.1%)
Gastrointestinal disorders
Dysphagia (difficulty swallowing)	33/35 (94.3%)		34/34 (100%)
Mucositis	34/35 (97.1%)		33/34 (97.1%)
Mucositis/Dysphagia	34/35 (97.1%)		34/34 (100%)
Nausea/Vomiting	27/35 (77.1%)		23/34 (67.6%)
Stomatitis	13/35 (37.1%)		18/34 (52.9%)
Injury, poisoning and procedural complications
Skin Toxicity from Radiation	33/35 (94.3%)		30/34 (88.2%)
Investigations
Increased Creatinine	9/35 (25.7%)		1/34 (2.9%)
Nervous system disorders
Cranial Neuropathy/ Hearing and Balance	1/35 (2.9%)		0/34 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.