Study of S-1, S-1/CDDP, and 5-FU/CDDP for Advanced Gastric Cancer

Phase 3

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: 5-FU plus CDDP; Drug: S-1; Drug: S-1 plus CDDP

• Registration Number: NCT00202969
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Brief Summary

This is an open-label, multicenter, three arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1 alone compared with S-1 plus CDDP, and S-1 plus CDDP compared with 5-FU plus CDDP in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be randomly assigned (1:1:1) to S-1 (Arm A), S-1/CDDP (Arm B) or 5-FU/CDDP (Arm C). Patients will be stratified to achieve balanced distribution of patients to each arm according to following stratifications, performance status (0, 1, or 2), the number of metastatic sites (1 vs \>1), prior gastrectomy, and center.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2007-01
• Study Completion: 2007-06
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-06
• Last Update Posted: 2011-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Non-prior chemotherapy treated advanced gastric adenocarcinoma
• Age 18 and over
• Performance status 0, 1, or 2 (ECOG)
• Life expectancy 3 months
• Hematopoietic WBC lower limit of normal-12,000/mm^3 Absolute granulocyte count ≥ 2,000/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL
• Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤ 1.5 mg/dL
• Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 60 mL/min

Exclusion Criteria

• Interstitial pneumonia, pulmonary fibrosis
• Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure
• Intestinal paralysis, intestinal obstruction, uncontrollable diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	5-FU plus CDDP	5-FU plus CDDP
1	S-1	S-1
2	S-1 plus CDDP	S-1 plus CDDP

Primary Outcome Measures

Name	Time	Method
Response rate	every course for first three courses, then every other course

Secondary Outcome Measures

Name	Time	Method
Safety profile, time to treatment failure	any time

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 No.52 Fu-Cheng Road, Hai-dian District, Beijing, China