Combination Chemotherapy and Surgery in Treating Patients With Locally Advanced Stomach Cancer

• Status: Completed
• Trial end date: 2006-03-01
• 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 chemotherapy drug with surgery may kill more tumor cells. It is not yet known if chemotherapy followed by surgery is more effective than surgery followed by chemotherapy for stomach cancer.

PURPOSE: This randomized phase III trial is studying surgery followed by combination chemotherapy to see how well it works compared to combination chemotherapy followed by surgery in treating patients with locally advanced stomach cancer.

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

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Cisplatin; Docetaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed locally advanced gastric carcinoma that is considered operable

• T3-4, Nx, M0 OR

• Tx, N+, M0

• Lymph nodes considered positive by sonography should be at least 2 of the following:

• Round

• Echopoor

• Sharp borders

• At least 0.5 cm

• No distant metastases, including peritoneal carcinomatosis

• CT scan and peritoneal lavage mandatory

PATIENT CHARACTERISTICS:

Age:

• 18 to 75

Performance status:

• 0-2

Life expectancy:

• Greater than 12 weeks

Hematopoietic:

• WBC at least 4,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin normal

• AST or ALT no greater than 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Adequate renal function within limits to allow for treatment with cisplatin

Cardiovascular:

• No unstable cardiac disease requiring treatment

• No congestive heart failure or angina pectoris even if medically controlled

• No significant arrhythmias

• No myocardial infarction within past 6 months

• Ejection fraction greater than 50% on cardiac sonography or MUGA scan

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other prior malignancy except basal cell carcinoma of the skin or adequately treated carcinoma in situ of the cervix

• No grade 2 or greater peripheral neuropathy of any origin (e.g., alcohol, diabetic)

• No history of anaphylaxis

• No other serious concurrent illness or medical condition that would preclude study therapy

• No history of significant neurologic or psychiatric disorders (e.g., psychotic disorders, dementia, or seizures)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent biologic therapy for gastric carcinoma

Chemotherapy:

• No other concurrent chemotherapy for gastric carcinoma

Endocrine therapy:

• No concurrent endocrine therapy for gastric carcinoma

Radiotherapy:

• No concurrent radiotherapy for gastric carcinoma

Surgery:

• See Disease Characteristics

Other:

• At least 30 days since prior treatment in a clinical trial

• No other concurrent experimental drugs

• No other concurrent anticancer therapy