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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-01197 | Other Identifier | NCI/CTRP |
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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.
OBJECTIVES:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Radiation with concurrent Cisplatin | Active Comparator | 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 | Experimental | Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse Free Survival | 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.. | at 2 yrs from start of study |
| Measure | Description | Time Frame |
|---|---|---|
| Patterns of Failure | 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 years from start of study |
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DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx
Must have locoregionally confined stage III (excluding T1-2, N1) or stage IV disease
Deemed appropriate for definitive non-operative management with curative intent
No primary cancer of the nasopharynx, paranasal sinus, or salivary gland
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
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Patients recruited from Cleveland, Ohio medical clinics from December 2007 to August 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Arm B: Radiation With Concurrent 5-FU and Cisplatin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Relapse Free Survival | 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.. | intention to treat (ITT) | Posted | Number | participants | at 2 yrs from start of study |
|
Adverse event data was collected over a 2 year period from study start.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cranial Neuropathy/ Hearing and Balance | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Adelstein | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | 216-444-9310 | adelstd@ccf.org |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| fluorouracil | Drug | Given IV |
|
| radiation therapy | Radiation | Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks |
|
|
| Overall Survival | Number of patients still alive from 2 years from start of study | 2 yrs from start of study |
| Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor | 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. | at 12 weeks after completing chemoradiotherapy |
| Number of Patients With a Pathological(Final)Complete Response | 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. | at 12 weeks after completing chemoradiotherapy and surgery |
| Disease Recurrence | 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. | 2 years after start of study |
| Number of Patients That Required a Feeding Tube | 12 weeks (after treatment) |
| Number of Patients That Required a Feeding Tube | 8 months after start of treatment |
| Number of Patients That Required a Feeding Tube | 12 months after start of treatment |
| Number of Patients That Required a Feeding Tube | 24 months after start of treatment |
| Nausea Level | 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. | 12 weeks (after treatment) |
| Nausea Level | 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. | 8 months from start of treatment |
| Nausea Level | 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 months from start of treatment |
| Nausea Level | Quality of life questionnaire asking "I have nausea". | 24 months from start of treatment |
| Dry Mouth | 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. | 12 weeks (after treatment) |
| Dry Mouth | 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. | 8 months from start of treatment |
| Dry Mouth | 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. | 12 months from start of treatment |
| Dry Mouth | 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. | 24 months from start of treatment |
| Pain | 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. | 12 weeks (after treatment) |
| Pain | 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. | 8 months from start of treatment |
| Pain | 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. | 12 months from start of treatment |
| Pain | 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. | 24 months from start of treatment |
| Quality of Life | 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. | 12 weeks (after treatment) |
| Quality of Life | 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. | 8 months from start of treatment |
| Quality of Life | 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. | 12 months from start of treatment |
| Quality of Life | 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 months from start of treatment |
| Eating | 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. | 12 weeks (after treatment) |
| Eating | 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. | 8 months from start of treatment |
| Eating | 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. | 12 months from start of treatment |
| Eating | 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. | 24 months from start of treatment |
| Swallowing | 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. | 12 weeks (after treatment) |
| Swallowing | 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. | 8 months after start of treatment |
| Swallowing | 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. | 12 months after start of treatment |
| Swallowing | 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. | 24 months after start of treatment |
| Alcohol Consumption | 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. | 12 weeks (after treatment) |
| Alcohol Consumption | 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. | 8 months after start of treatment |
| Alcohol Consumption | 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. | 12 months after start of treatment |
| Alcohol Consumption | 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. | 24 months after start of treatment |
| Solid Foods | 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. | 12 weeks (after treatment) |
| Solid Foods | 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. | 8 months after start of treatment |
| Solid Foods | 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. | 12 months after start of treatment |
| Solid Foods | 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. | 24 months after start of treatment |
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Patterns of Failure | 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. | intention to treat (ITT) | Posted | Number | participants | 2 years from start of study |
|
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| Secondary | Overall Survival | Number of patients still alive from 2 years from start of study | intention to treat (ITT) | Posted | Number | participants | 2 yrs from start of study |
|
|
|
| Secondary | Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor | 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. | intention to treat (ITT) | Posted | Number | participants | at 12 weeks after completing chemoradiotherapy |
|
|
|
| Secondary | Number of Patients With a Pathological(Final)Complete Response | 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. | Posted | Number | participants | at 12 weeks after completing chemoradiotherapy and surgery |
|
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| Secondary | Disease Recurrence | 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. | Patients that had a complete response after 12 weeks of therapy | Posted | Number | participants | 2 years after start of study |
|
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| Secondary | Number of Patients That Required a Feeding Tube | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Number | participants | 12 weeks (after treatment) |
|
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| Secondary | Number of Patients That Required a Feeding Tube | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Number | participants | 8 months after start of treatment |
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| Secondary | Number of Patients That Required a Feeding Tube | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Number | participants | 12 months after start of treatment |
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| Secondary | Number of Patients That Required a Feeding Tube | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Number | participants | 24 months after start of treatment |
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| Secondary | Nausea Level | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks (after treatment) |
|
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| Secondary | Nausea Level | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 8 months from start of treatment |
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| Secondary | Nausea Level | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 months from start of treatment |
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| Secondary | Nausea Level | Quality of life questionnaire asking "I have nausea". | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 24 months from start of treatment |
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| Secondary | Dry Mouth | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks (after treatment) |
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| Secondary | Dry Mouth | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 8 months from start of treatment |
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| Secondary | Dry Mouth | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 months from start of treatment |
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| Secondary | Dry Mouth | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 24 months from start of treatment |
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| Secondary | Pain | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks (after treatment) |
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| Secondary | Pain | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 8 months from start of treatment |
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| Secondary | Pain | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 months from start of treatment |
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| Secondary | Pain | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 24 months from start of treatment |
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| Secondary | Quality of Life | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks (after treatment) |
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| Secondary | Quality of Life | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 8 months from start of treatment |
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| Secondary | Quality of Life | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 months from start of treatment |
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| Secondary | Quality of Life | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 24 months from start of treatment |
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| Secondary | Eating | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks (after treatment) |
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| Secondary | Eating | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 8 months from start of treatment |
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| Secondary | Eating | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 months from start of treatment |
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| Secondary | Eating | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 24 months from start of treatment |
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| Secondary | Swallowing | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks (after treatment) |
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| Secondary | Swallowing | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 8 months after start of treatment |
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| Secondary | Swallowing | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 months after start of treatment |
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| Secondary | Swallowing | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 24 months after start of treatment |
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| Secondary | Alcohol Consumption | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks (after treatment) |
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| Secondary | Alcohol Consumption | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 8 months after start of treatment |
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| Secondary | Alcohol Consumption | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 months after start of treatment |
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| Secondary | Alcohol Consumption | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 24 months after start of treatment |
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| Secondary | Solid Foods | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks (after treatment) |
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| Secondary | Solid Foods | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 8 months after start of treatment |
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| Secondary | Solid Foods | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 months after start of treatment |
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| Secondary | Solid Foods | 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. | Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | 24 months after start of treatment |
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| 7 |
| 35 |
| 35 |
| 35 |
| EG001 | 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. | 14 | 34 | 34 | 34 |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Cardiac | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Cranial Neuropathy/ Hearing and Balance | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Hypokalemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
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| Malnutrition | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Mucositis/Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Nausea/Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Pain - Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Non-systematic Assessment |
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| Pain-not otherwise specified (NOS) | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
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| Renal Insufficiency | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Thrombosis/embolism | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Hypothyroidism | Endocrine disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Increased Creatinine | Investigations | CTCAE (3.0) | Non-systematic Assessment |
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| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Mucositis/Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Nausea/Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Skin Toxicity from Radiation | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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Not provided
Not provided
Not provided
| D009375 |
| Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D014498 |
| Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
| Distant recurrence |
|