Overview

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

Status:
Completed
Trial end date:
2005-03-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Treatments:
Cisplatin
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