S-1 and Cisplatin in Treating Patients Who Are Undergoing Surgery for Stage III Stomach Cancer

NCT ID: NCT00182611

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2008-11-30

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may shrink the tumor so that it can be removed. It is not yet known whether giving S-1 together with cisplatin before surgery is more effective than surgery followed by S-1 in treating stomach cancer.

PURPOSE: This randomized phase III trial is studying how well giving S-1 together with cisplatin before surgery works compared to surgery followed by S-1 in treating patients with stage III stomach cancer.

Detailed Description

OBJECTIVES:

Primary

• Compare the overall survival of patients with potentially resectable stage III gastric cancer treated with neoadjuvant S-1 and cisplatin followed by gastrectomy and adjuvant S-1 vs no neoadjuvant chemotherapy before gastrectomy and adjuvant S-1.

Secondary

• Compare the progression-free survival of patients treated with these regimens.
• Compare the curative resection rates in patients treated with these regimens.
• Compare the safety of these regimens, in terms of postoperative complications, adverse events, and treatment- or surgery-related mortality rate, in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (T3 vs T4) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.

• Arm I (control): Patients undergo gastrectomy with D2+ lymph node dissection. Patients then receive adjuvant oral S-1.
• Arm II (neoadjuvant therapy): Patients receive neoadjuvant oral S-1 on days 1-21 and cisplatin IV over 2 hours on day 8. Treatment repeats every 35 days for 2 courses in the absence of disease progression. Patients then undergo surgery and receive adjuvant S-1 as in arm I.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

cisplatin

Intervention Type: DRUG

tegafur-gimeracil-oteracil potassium

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

conventional surgery

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed gastric adenocarcinoma, including type II or type III adenocarcinoma of the esophagogastric junction

• Stage III disease

• T3 or T4 and/or N2

• No stage IV disease
• Helical CT scan and laparoscopic staging required
• Potentially resectable disease

PATIENT CHARACTERISTICS:

Age

• 20 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 4,000/mm³, but < 12,000/mm³
• Granulocyte count ≥ 2,000/mm³
• Platelet count ≥ 100,000/mm³
• 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

• Arterial oxygen pressure (PaO_2) ≥ 70 mm Hg on room air

Other

• Able to take oral medications

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyoto University

OTHER

Sponsor Role: lead

Principal Investigators

Seiji Satoh

Role: STUDY_CHAIR

Kyoto University Hospital

Locations

Fukui Red Cross Hospital

Fukui-shi, Fukui, Japan

Kyoto University Hospital

Kyoto, Kyoto, Japan

National Hospital Organization - Kyoto Medical Center

Kyoto, Kyoto, Japan

Yamato Municipal Hospital

Yamatotakada, Nara, Japan

Kitano Hospital

Osaka, Osaka, Japan

Shimane Prefectural Central Hospital

Izumo-shi, Shimane, Japan

Countries

Japan

Other Identifiers

CDR0000426403

Identifier Type: REGISTRY

Identifier Source: secondary_id

KYUH-UHA-GC04-03

Identifier Type: -

Identifier Source: org_study_id