Head and Neck Cancer
Conditions
Keywords
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
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.
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.
Interventions
DRUGcisplatin
Given IV
DRUGfluorouracil
Given IV
RADIATIONradiation therapy
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 2 yrs from start of study | Number of patients still alive from 2 years from start of study |
| 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. |
| 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. |
| 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. |
| Number of Patients That Required a Feeding Tube | 12 weeks (after treatment) | — |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
Patients recruited from Cleveland, Ohio medical clinics from December 2007 to August 2012.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| 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. | 34 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 2 |
| Overall Study | Patient non-compliant | 0 | 1 |
Baseline characteristics
| Characteristic | Arm A: Radiation With Concurrent Cisplatin | Arm B: Radiation With Concurrent 5-FU and Cisplatin | Total |
|---|---|---|---|
| Age, Customized 40-49 years | 6 participants | 10 participants | 16 participants |
| Age, Customized 50-59 years | 11 participants | 16 participants | 27 participants |
| Age, Customized 60-69 years | 17 participants | 6 participants | 23 participants |
| Age, Customized 70-79 years | 1 participants | 2 participants | 3 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 34 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 33 Participants | 68 Participants |
| Region of Enrollment United States | 35 participants | 34 participants | 69 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 32 Participants | 28 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 35 / 35 | 34 / 34 |
| serious Total, serious adverse events | 7 / 35 | 14 / 34 |
Outcome results
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..
Time frame: at 2 yrs from start of study
Population: intention to treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A | Relapse Free Survival | 30 participants |
| Arm B | Relapse Free Survival | 28 participants |
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.
Time frame: 24 months after start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Alcohol Consumption | 2.85 units on a scale | Standard Deviation 0.88 |
| Arm B | Alcohol Consumption | 2.81 units on a scale | Standard Deviation 0.66 |
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.
Time frame: 12 months after start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Alcohol Consumption | 2.85 units on a scale | Standard Deviation 0.72 |
| Arm B | Alcohol Consumption | 2.91 units on a scale | Standard Deviation 0.73 |
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.
Time frame: 8 months after start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Alcohol Consumption | 2.96 units on a scale | Standard Deviation 0.89 |
| Arm B | Alcohol Consumption | 3.00 units on a scale | Standard Deviation 0.85 |
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.
Time frame: 12 weeks (after treatment)
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Alcohol Consumption | 3.28 units on a scale | Standard Deviation 0.65 |
| Arm B | Alcohol Consumption | 3.27 units on a scale | Standard Deviation 0.87 |
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.
Time frame: 2 years after start of study
Population: Patients that had a complete response after 12 weeks of therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A | Disease Recurrence | 5 participants |
| Arm B | Disease Recurrence | 2 participants |
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.
Time frame: 8 months from start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Dry Mouth | 2.67 units on a scale | Standard Deviation 1.07 |
| Arm B | Dry Mouth | 3.09 units on a scale | Standard Deviation 0.85 |
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.
Time frame: 24 months from start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Dry Mouth | 2.60 units on a scale | Standard Deviation 1.1 |
| Arm B | Dry Mouth | 2.94 units on a scale | Standard Deviation 1.29 |
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.
Time frame: 12 months from start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Dry Mouth | 2.70 units on a scale | Standard Deviation 1.03 |
| Arm B | Dry Mouth | 3.09 units on a scale | Standard Deviation 0.92 |
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.
Time frame: 12 weeks (after treatment)
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Dry Mouth | 3.33 units on a scale | Standard Deviation 0.83 |
| Arm B | Dry Mouth | 3.08 units on a scale | Standard Deviation 1.15 |
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.
Time frame: 12 weeks (after treatment)
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Eating | 2.33 units on a scale | Standard Deviation 1.07 |
| Arm B | Eating | 2.28 units on a scale | Standard Deviation 1.02 |
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.
Time frame: 8 months from start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Eating | 1.93 units on a scale | Standard Deviation 1.17 |
| Arm B | Eating | 1.78 units on a scale | Standard Deviation 0.95 |
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.
Time frame: 12 months from start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Eating | 1.56 units on a scale | Standard Deviation 1.25 |
| Arm B | Eating | 1.24 units on a scale | Standard Deviation 1.09 |
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.
Time frame: 24 months from start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Eating | 1.52 units on a scale | Standard Deviation 1.17 |
| Arm B | Eating | 1.13 units on a scale | Standard Deviation 1.09 |
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.
Time frame: 12 weeks (after treatment)
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Nausea Level | 0.07 units on a scale | Standard Deviation 0.26 |
| Arm B | Nausea Level | 0.12 units on a scale | Standard Deviation 0.33 |
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.
Time frame: 8 months from start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Nausea Level | 0.15 units on a scale | Standard Deviation 0.46 |
| Arm B | Nausea Level | 0.09 units on a scale | Standard Deviation 0.29 |
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.
Time frame: 12 months from start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Nausea Level | 0.14 units on a scale | Standard Deviation 0.45 |
| Arm B | Nausea Level | 0.04 units on a scale | Standard Deviation 0.21 |
Secondary
Nausea Level
Quality of life questionnaire asking I have nausea.
Time frame: 24 months from start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Nausea Level | 0.10 units on a scale | Standard Deviation 0.3 |
| Arm B | Nausea Level | 0 units on a scale | Standard Deviation 0 |
Secondary
Number of Patients That Required a Feeding Tube
Time frame: 12 months after start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A | Number of Patients That Required a Feeding Tube | 0 participants |
| Arm B | Number of Patients That Required a Feeding Tube | 0 participants |
Secondary
Number of Patients That Required a Feeding Tube
Time frame: 12 weeks (after treatment)
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A | Number of Patients That Required a Feeding Tube | 0 participants |
| Arm B | Number of Patients That Required a Feeding Tube | 3 participants |
Secondary
Number of Patients That Required a Feeding Tube
Time frame: 24 months after start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A | Number of Patients That Required a Feeding Tube | 0 participants |
| Arm B | Number of Patients That Required a Feeding Tube | 0 participants |
Secondary
Number of Patients That Required a Feeding Tube
Time frame: 8 months after start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A | Number of Patients That Required a Feeding Tube | 0 participants |
| Arm B | Number of Patients That Required a Feeding Tube | 0 participants |
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.
Time frame: at 12 weeks after completing chemoradiotherapy
Population: intention to treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A | Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor | 35 participants |
| Arm B | Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor | 28 participants |
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.
Time frame: at 12 weeks after completing chemoradiotherapy and surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A | Number of Patients With a Pathological(Final)Complete Response | 35 participants |
| Arm B | Number of Patients With a Pathological(Final)Complete Response | 31 participants |
Secondary
Overall Survival
Number of patients still alive from 2 years from start of study
Time frame: 2 yrs from start of study
Population: intention to treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A | Overall Survival | 34 participants |
| Arm B | Overall Survival | 29 participants |
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.
Time frame: 12 weeks (after treatment)
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Pain | 1.24 units on a scale | Standard Deviation 1.06 |
| Arm B | Pain | 1.42 units on a scale | Standard Deviation 0.95 |
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.
Time frame: 8 months from start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Pain | 0.65 units on a scale | Standard Deviation 0.8 |
| Arm B | Pain | 0.74 units on a scale | Standard Deviation 0.81 |
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.
Time frame: 12 months from start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Pain | 0.57 units on a scale | Standard Deviation 0.74 |
| Arm B | Pain | 0.57 units on a scale | Standard Deviation 0.79 |
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.
Time frame: 24 months from start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Pain | 0.60 units on a scale | Standard Deviation 0.75 |
| Arm B | Pain | 0.75 units on a scale | Standard Deviation 1 |
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.
Time frame: 2 years from start of study
Population: intention to treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A | Patterns of Failure | Distant recurrence | 4 participants |
| Arm A | Patterns of Failure | Local recurrence | 1 participants |
| Arm A | Patterns of Failure | Regional (nodal) recurrence | 1 participants |
| Arm B | Patterns of Failure | Regional (nodal) recurrence | 0 participants |
| Arm B | Patterns of Failure | Distant recurrence | 4 participants |
| Arm B | Patterns of Failure | Local recurrence | 1 participants |
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.
Time frame: 12 weeks (after treatment)
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Quality of Life | 1.37 units on a scale | Standard Deviation 1.08 |
| Arm B | Quality of Life | 1.68 units on a scale | Standard Deviation 1.14 |
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.
Time frame: 8 months from start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Quality of Life | 0.85 units on a scale | Standard Deviation 1.13 |
| Arm B | Quality of Life | 1.13 units on a scale | Standard Deviation 1.18 |
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.
Time frame: 24 months from start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Quality of Life | 0.62 units on a scale | Standard Deviation 0.86 |
| Arm B | Quality of Life | 0.88 units on a scale | Standard Deviation 0.81 |
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.
Time frame: 12 months from start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Quality of Life | 0.67 units on a scale | Standard Deviation 1 |
| Arm B | Quality of Life | 0.95 units on a scale | Standard Deviation 0.84 |
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.
Time frame: 8 months after start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Solid Foods | 0.96 units on a scale | Standard Deviation 1.15 |
| Arm B | Solid Foods | 1.13 units on a scale | Standard Deviation 1.06 |
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.
Time frame: 12 months after start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Solid Foods | 0.78 units on a scale | Standard Deviation 0.97 |
| Arm B | Solid Foods | 0.70 units on a scale | Standard Deviation 0.93 |
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.
Time frame: 24 months after start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Solid Foods | 0.85 units on a scale | Standard Deviation 0.93 |
| Arm B | Solid Foods | 0.56 units on a scale | Standard Deviation 0.89 |
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.
Time frame: 12 weeks (after treatment)
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Solid Foods | 1.41 units on a scale | Standard Deviation 1.35 |
| Arm B | Solid Foods | 1.73 units on a scale | Standard Deviation 1.15 |
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.
Time frame: 12 weeks (after treatment)
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Swallowing | 1.93 units on a scale | Standard Deviation 1.07 |
| Arm B | Swallowing | 2.31 units on a scale | Standard Deviation 0.97 |
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.
Time frame: 12 months after start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Swallowing | 1.61 units on a scale | Standard Deviation 1.13 |
| Arm B | Swallowing | 1.52 units on a scale | Standard Deviation 1.16 |
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.
Time frame: 8 months after start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Swallowing | 1.31 units on a scale | Standard Deviation 1.12 |
| Arm B | Swallowing | 1.83 units on a scale | Standard Deviation 1.03 |
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.
Time frame: 24 months after start of treatment
Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Swallowing | 1.45 units on a scale | Standard Deviation 1 |
| Arm B | Swallowing | 1.63 units on a scale | Standard Deviation 1.2 |