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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
cisplatin
fluorouracil
radiation therapy
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A: Radiation with concurrent Cisplatin

Arm B: Radiation with concurrent 5-FU and Cisplatin

Arm 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.

Outcomes

Primary Outcome Measures

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..

Secondary Outcome Measures

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.
Overall Survival
Number of patients still alive from 2 years 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.
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.
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.
Number of Patients That Required a Feeding Tube
Number of Patients That Required a Feeding Tube
Number of Patients That Required a Feeding Tube
Number of Patients That Required a Feeding Tube
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.
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.
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.
Nausea Level
Quality of life questionnaire asking "I have nausea".
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 30, 2008
Last Updated
July 23, 2020
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00608205
Brief Title
Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Radiation with concurrent Cisplatin
Arm Type
Active Comparator
Arm 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.
Arm Title
Arm B: Radiation with concurrent 5-FU and Cisplatin
Arm Type
Experimental
Arm Description
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
CDDP
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Other Intervention Name(s)
radiation
Intervention Description
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
Title
Overall Survival
Description
Number of patients still alive from 2 years from start of study
Time Frame
2 yrs from start of study
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
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
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
Title
Number of Patients That Required a Feeding Tube
Time Frame
12 weeks (after treatment)
Title
Number of Patients That Required a Feeding Tube
Time Frame
8 months after start of treatment
Title
Number of Patients That Required a Feeding Tube
Time Frame
12 months after start of treatment
Title
Number of Patients That Required a Feeding Tube
Time Frame
24 months after start of treatment
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)
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
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
Title
Nausea Level
Description
Quality of life questionnaire asking "I have nausea".
Time Frame
24 months from start of treatment
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)
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
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
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
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)
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
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
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
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)
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
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
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
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)
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
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
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
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)
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
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
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
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)
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
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
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
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)
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J. Adelstein, MD
Organizational Affiliation
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Panayiotis Savvides, MD
Organizational Affiliation
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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