Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Cancer of the Esophagus

• Status: Completed
• Trial end date: 1969-12-31
• 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. It is not known whether high-dose radiation therapy is more effective than standard dose radiation therapy in treating cancer of the esophagus.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus high- or standard-dose radiation therapy in treating patients with cancer of the esophagus.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborators: Eastern Cooperative Oncology Group; National Cancer Institute (NCI); North Central Cancer Treatment Group
• Treatments: Fluorouracil

Criteria

DISEASE CHARACTERISTICS: Biopsy-proven primary squamous cell or adenocarcinoma of the esophagus Clinical Stage T1-4, Nx, M0 disease required Disease entirely confined to the esophagus and periesophageal soft tissue with no tumor extension within 2 cm proximal to the stomach No biopsy-proven invasion of the tracheal-bronchial tree or tracheal-esophageal (TE) fistula Bronchoscopy of tracheal-bronchial tree required for lesions less than 30 cm from the incisors to exclude TE fistula Negative liver biopsy required if liver CT suggestive of metastatic disease Negative biopsy required for enlarged (1.5 cm or greater) retroperitoneal or celiac nodes seen on CT Negative biopsy of clinically or radiographically positive supraclavicular nodes required with cervical primaries No recurrent disease No multiple carcinomas of the esophagus

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100% Hematopoietic: WBC at least 4,000 Platelets at least 150,000 Hb at least 10 g/dL Hepatic: Not specified Renal: Creatinine normal OR Creatinine clearance at least 65 mL/min Nutrition: Recommended oral intake requirements (by mouth or tube feeding): More than 1.5 x Basal Energy Expenditure (BEE) measured by Harris- Benedict equation OR More than 1,000 calories/sqm of body surface area (BSA) Intravenous hyperalimentation (recommended if inadequate oral intake): 1.75-2.25 x BEE OR 1,200-1,600 calories/sqm BSA Upper limits may be waived for hypermetabolic patients Other: No second malignancy within 5 years except: Curable nonmelanomatous skin cancer Cervical cancer in situ No pregnant or nursing women

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior or concurrent growth factor administration Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior chest irradiation Surgery: No prior resection