A PHASE III INTERGROUP RANDOMIZED COMPARISON OF COMBINED MODALITY THERAPY FOR CARCINOMA OF THE ESOPHAGUS: HIGH-DOSE VS CONVENTIONAL-DOSE RADIATION THERAPY

Inclusion 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