Overview

SWOG-9451, Combination Chemo & RT For Patients With Stage III/Stage IV Cancer of the Hypopharynx or Tongue

Status:
Terminated
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 more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients with stage III or stage IV cancer of the hypopharynx or tongue.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Southwest Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cisplatin
Cobalt
Fluorouracil
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the
hypopharynx or base of the tongue that is newly diagnosed and considered resectable For
hypopharyngeal cancer, total laryngectomy would be required surgery Disease staged by
clinical exam, endoscopy, and CT or MRI Stage III that is T2-3 N0-1 M0 Stage IV that is
T2-3 N2-3 M0 Measurable or evaluable disease other than pleural effusion, ascites, or
disease documented by indirect evidence Closed to patients with cancer of the base of
tongue as of 11/15/1998

PATIENT CHARACTERISTICS: Age: Adult Performance status: SWOG 0 or 1 Hematopoietic: WBC at
least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than 2 times normal AST or ALT no greater than 3
times normal Renal: Creatinine no greater than 2 times normal Creatinine clearance at least
60 mL/min Magnesium normal (supplementation allowed) Other: Average hearing loss in both
ears no greater than 40 dB in 50-2,000 Hz range No second malignancy within 5 years except:
Adequately treated nonmelanomatous skin cancer Carcinoma in situ of the cervix Stage I/II
cancer (other than head/neck) in complete remission Not pregnant or nursing Effective
contraception required of fertile patients

PRIOR CONCURRENT THERAPY: No prior therapy