Cisplatin and Radiation Therapy in Treating Patients With Stage IV Cancer of the Head and Neck

Radiation Therapy Oncology Group

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

Treatments: Radiation: radiation therapy; Drug: cisplatin

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT00002932

RTOG-9615

CDR0000065366

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cisplatin and radiation therapy in treating patients with stage IV cancer of the head and neck.

Full description

OBJECTIVES: I. Determine the percentage of patients for whom a complete course of therapy can be administered using targeted supradose cisplatin chemoradiation in patients with squamous cell carcinoma of the head and neck. II. Determine the partial and complete response rate of cisplatin chemoradiation. III. Determine the incidence of adverse events using cisplatin chemoradiation therapy. IV. Determine the rate of disease-free survival and overall survival in these patients. V. Determine the incidence and pattern of recurrence in these patients. VI. Document quality of life measured by disease-specific instruments in these patients.

OUTLINE: All patients receive four courses of cisplatin on days 1, 8, 15, and 22 concurrent with radiotherapy. One course of chemotherapy consists of intra-arterial cisplatin given over 3-5 minutes. Radiotherapy is given 5 days a week for 7 weeks. This weekly cisplatin chemoradiation course will be repeated 4 times, providing recovery from toxicity is present. Dexamethasone is started the evening prior to cisplatin treatment, and continues until the morning following the procedure.

PROJECTED ACCRUAL: 60 patients will be enrolled.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx No distant metastatic disease No previous or concurrent head and neck primaries No lip, nasopharynx, or salivary gland lesions No recurrent tumors Stage IV disease comprised of T4 NO-3 lesions

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky greater than 60 Life Expectancy: Not specified Hematopoietic: ANC greater than 2,000 Platelet count greater than 100,000 Hepatic: Not specified Renal: Creatinine clearance greater than 50 mL/min Cardiovascular: Not specified Other: Not pregnant or nursing No adverse medical illnesses No imaging studies performed greater than one month preregistration No laboratory studies greater than 2 weeks preregistration No other malignancies, except for basal or squamous cell of the skin, within the past 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the head and neck Surgery: No prior surgery to study site other than a biopsy Other: Protocol treatment must begin within 8 weeks of biopsy