Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus

• Status: Completed
• Trial end date: 2010-08-01
• 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. It is not known whether combining chemotherapy with surgery is more effective than surgery alone.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients with cancer of the esophagus.

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

Details

• Lead Sponsor: UNICANCER
• Treatments: Cisplatin; Fluorouracil

Criteria

DISEASE CHARACTERISTICS:

• Adenocarcinoma of the lower third of the esophagus or the cardia for which complete resection is feasible

• Extension to the cardia allowed

• Cancer of the cardia with extension to the esophagus or stomach allowed

• No in situ cancer of the cardia

• No distant metastases

PATIENT CHARACTERISTICS:

Age:

• Not over 75

Performance status:

• WHO 0 or 1

Hematopoietic:

• WBC at least 4,000

• Polymorphonuclear lymphocytes greater than 2,000

• Platelets at least 100,000

Hepatic:

• Not specified

Renal:

• Creatinine less than 1.3 mg/dL (120 micromoles/L)

Cardiovascular:

• No prior myocardial infarction

• No other cardiac contraindication to surgery

Pulmonary:

• No respiratory contraindication to surgery

Other:

• No second malignancy except:

• Basal cell carcinoma of the skin

• Adequately treated in situ carcinoma of the uterine cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for tumors of the cardia

Endocrine therapy

• No prior radiotherapy for tumors of the cardia

Radiotherapy

• Not specified

Surgery

• Not specified