Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatments cisplatin, fluorouracil, radiation therapy
Phase phase 3
Sponsor Case Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date January 2008
End date September 2012
Trial size 69 participants
Trial identifier NCT00608205, CASE3307, NCI-2010-01197, P30CA043703

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
cisplatin CDDP
Given IV
radiation therapy radiation
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks
(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.
cisplatin CDDP
Given IV
fluorouracil fluorouracil
Given IV
radiation therapy radiation
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks

Primary Outcomes

Measure
Relapse Free Survival
time frame: at 2 yrs from start of study

Secondary Outcomes

Measure
Patterns of Failure
time frame: 2 years from start of study
Overall Survival
time frame: 2 yrs from start of study
Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor
time frame: at 12 weeks after completing chemoradiotherapy
Number of Patients With a Pathological(Final)Complete Response
time frame: at 12 weeks after completing chemoradiotherapy and surgery
Disease Recurrence
time frame: 2 years after start of study
Number of Patients That Required a Feeding Tube
time frame: 12 weeks (after treatment)
Number of Patients That Required a Feeding Tube
time frame: 8 months after start of treatment
Number of Patients That Required a Feeding Tube
time frame: 12 months after start of treatment
Number of Patients That Required a Feeding Tube
time frame: 24 months after start of treatment
Nausea Level
time frame: 12 weeks (after treatment)
Nausea Level
time frame: 8 months from start of treatment
Nausea Level
time frame: 12 months from start of treatment
Nausea Level
time frame: 24 months from start of treatment
Dry Mouth
time frame: 12 weeks (after treatment)
Dry Mouth
time frame: 8 months from start of treatment
Dry Mouth
time frame: 12 months from start of treatment
Dry Mouth
time frame: 24 months from start of treatment
Pain
time frame: 12 weeks (after treatment)
Pain
time frame: 8 months from start of treatment
Pain
time frame: 12 months from start of treatment
Pain
time frame: 24 months from start of treatment
Quality of Life
time frame: 12 weeks (after treatment)
Quality of Life
time frame: 8 months from start of treatment
Quality of Life
time frame: 12 months from start of treatment
Quality of Life
time frame: 24 months from start of treatment
Eating
time frame: 12 weeks (after treatment)
Eating
time frame: 8 months from start of treatment
Eating
time frame: 12 months from start of treatment
Eating
time frame: 24 months from start of treatment
Swallowing
time frame: 12 weeks (after treatment)
Swallowing
time frame: 8 months after start of treatment
Swallowing
time frame: 12 months after start of treatment
Swallowing
time frame: 24 months after start of treatment
Alcohol Consumption
time frame: 12 weeks (after treatment)
Alcohol Consumption
time frame: 8 months after start of treatment
Alcohol Consumption
time frame: 12 months after start of treatment
Alcohol Consumption
time frame: 24 months after start of treatment
Solid Foods
time frame: 12 weeks (after treatment)
Solid Foods
time frame: 8 months after start of treatment
Solid Foods
time frame: 12 months after start of treatment
Solid Foods
time frame: 24 months after start of treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator David J. Adelstein, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Case Comprehensive Cancer Center.