Combination Chemotherapy Plus Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Esophagus or Stomach

• 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. Combining chemotherapy and radiation therapy may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy plus radiation therapy with and without fluorouracil in treating patients who have cancer of the esophagus or stomach.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Fluorouracil; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction

• Stage I-III (T1, N1, M0; T2-4, N any, M0)

• Supraclavicular or celiac lymph node involvement allowed

• Disease entirely confined to the esophagus or gastroesophageal junction and peri-esophageal soft tissue

• Cervical esophageal carcinoma allowed

• No tumor extension beyond 2 cm into stomach

• No multiple primary carcinomas of the esophagus

• No evidence of disseminated cancer

• No tracheoesophageal fistula or direct invasion into the mucosa of the trachea or major bronchi

• Bronchoscopy with biopsy and cytology required if the primary carcinoma is less than 26 cm from the incisors or is at or above the carina by imaging study

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• Zubrod 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 150,000/mm^3

• Hemoglobin at least 10 g/dL

Hepatic:

• Not specified

Renal:

• Creatinine no greater than 1.5 mg/dL

• Creatinine clearance at least 65 mL/min

Cardiovascular:

• No uncontrolled heart disease

• No uncontrolled hypertension

Other:

• Total oral/enteral intake must be at least 1,700 kCal/day

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No uncontrolled diabetes

• No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior systemic chemotherapy

• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior chest radiotherapy

Surgery:

• No prior major esophageal surgery