Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer

• Status: Completed
• Trial end date: 2003-12-01
• 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. Combining more than one drug may kill more tumor cells. It is not known whether receiving chemotherapy before surgery may be more effective than surgery alone in treating patients with stomach cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus combination chemotherapy with surgery alone in treating patients with stomach cancer.

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

Details

• Lead Sponsor: Medical Research Council
• Treatments: Epirubicin; Fluorouracil

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven resectable stage II or III adenocarcinoma of the stomach

• No evidence of locally inoperable or distant metastases on chest x-ray and any combination of abdominal ultrasound, CT scan, or laparoscopy

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• WHO 0-1

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Creatinine clearance greater than 60 mL/min

Cardiovascular:

• No clinical evidence of uncontrolled angina pectoris, cardiac failure, or significant uncontrolled cardiac arrhythmia

Other:

• No medical contraindication to study therapy

• No other prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix

• Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• See Disease Characteristics