NCT00005088

Radiation Therapy and Cisplatin in Treating Patients With Advanced Head and Neck Cancer

Official Title:

A Phase II Trial of Concomitant Boost Radiation and Concurrent Cisplatin for Advanced Head and Neck Carcinomas

Summary

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

PURPOSE: Phase II trial to study the effectiveness of radiation therapy and cisplatin in treating patients who have advanced head and neck cancer.

Eligibility

DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx Stage III or IV No distant metastases

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-1 Life expectancy: At least 6 months Hematopoietic: Absolute granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 50 mL/min Calcium normal Cardiovascular: No symptomatic coronary artery disease No angina No myocardial infarction within the past 6 months Other: Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 3 years except nonmelanomatous skin cancer

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 initial surgery (except diagnostic biopsy of the primary site or neck)

Disease(s) and\or Condition(s)

Head and Neck Cancer

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: cisplatin
    • Description:
    • Arm Group Labels:
    • Type: RADIATION
    • Name: radiation therapy
    • Description:
    • Arm Group Labels:
Sponsor
  • Radiation Therapy Oncology Group