S-1 and Cisplatin Before Surgery in Treating Patients With Stage IV Gastric Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well giving S-1 together with cisplatin works in treating patients who are undergoing surgery for stage IV gastric cancer.

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

Details

• Lead Sponsor: Kyoto University
• Treatments: Cisplatin; Tegafur

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed gastric adenocarcinoma

• Stage IV disease meeting 1 of the following staging criteria according to Japanese gastric cancer classification:

• T4, N2

• T4, N3

• P1, CY1

• CT scan and laparoscopic staging required

PATIENT CHARACTERISTICS:

Age

• 20 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 4,000/mm^3 AND < 12,000/mm^3

• Granulocyte count ≥ 2,000/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 9.0 g/dL

Hepatic

• AST and ALT ≤ 2.5 times upper limit of normal

• Bilirubin ≤ 1.5 mg/dL

Renal

• Creatinine clearance ≥ 50 mL/min

Pulmonary

• PaO_2 ≥ 70 mm Hg on room air

Other

• Able to swallow oral medication

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for gastric cancer

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy for gastric cancer

Surgery

• No prior surgery for gastric cancer

Other

• No other prior therapy for gastric cancer