Phase III Study of Hyperfractionated Radiation Therapy With or Without Simultaneaous Application of CIS-Platinum in Patients With Moderately Advanced to Advanced Cancers of the Head and Neck
chemotherapy
+ cisplatin
+ low-LET cobalt-60 gamma ray therapy
Carcinoma+5
+ Carcinoma, Squamous Cell
+ Neoplasms
Treatment Study
Summary
Study start date: April 1, 1994
Actual date on which the first participant was enrolled.OBJECTIVES: I. Assess the time to treatment failure (local and regional) in patients with moderately advanced and advanced squamous cell carcinoma of the head and neck (no distant metastases) when treated with hyperfractionated radiotherapy with vs. without 2 courses of simultaneously administered cisplatin. II. Assess the time to distant metastatic relapse, overall survival, and toxicity in patients receiving these treatments. III. Evaluate whether the potential tumor-doubling time is an indicator for risk of treatment failure in patients receiving these treatments. OUTLINE: Randomized study. Arm I: Radiotherapy plus Single-Agent Chemotherapy followed, as indicated, by Surgery. Hyperfractionated external-beam tumor irradiation using photon energies of 4-6 MV or electrons of 6-12 MV (interstitial brachytherapy boost to lesions of the oral cavity allowed); plus Cisplatin, CDDP, NSC-119875; followed, in patients with persistent disease (at the discretion of the surgeon), by resection of primary tumor or involved nodes. Arm II: Hyperfractionated radiotherapy followed by Surgery. Tumor irradiation as in Arm I; followed by resection as in Arm I. PROJECTED ACCRUAL: At least 400 patients will be accrued over 5 years. Interim analyses to allow for early stopping will be carried out after entry of 50 and 100 patients.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.224 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 20 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically documented squamous cell cancer of the head and neck in the following sites: Hypopharynx Larynx Oral cavity Oropharynx Stage III/IV disease No distant metastases by the following: Chest x-ray (all patients) Liver ultrasound or CT and bone scintigraphy (all hypopharyngeal cancers, those with involved lower neck nodes, and as clinically indicated) Multiple sites of disease eligible provided radiotherapy treatment volume remains acceptable PATIENT CHARACTERISTICS: Age: 20 to 75 Performance status: WHO 0-2 Hematopoietic: WBC greater than 3,000 Platelets greater than 100,000 Hepatic: Not specified Renal: Creatinine clearance at least 60 ml/min No renal disease or impairment of renal function Cardiovascular: No coronary heart disease No cardiac failure No history of pulmonary embolism within 2 years Other: No clinical hearing impairment No peripheral neuropathy with concomitant handicap No severe diabetes mellitus with serious vasculopathy or neuropathy No second cancer except: Nonmelanomatous skin or lip cancer In situ carcinoma of the cervix Blood/body fluid analyses to determine eligibility completed within 14 days prior to registration PRIOR CONCURRENT THERAPY: No prior treatment for head and neck cancer Excisional biopsy for diagnosis allowed
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location