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

Study Overview
=================
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.

Official Title
-----------------
An Open-label, Multicenter, Randomized, 3 Arm Study of S-1 Compared With S-1/CDDP, or S-1/CDDP Compared With 5-FU/CDDP in Patients With Advanced Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: S-1
* Drug: S-1 plus CDDP
* Drug: 5-FU plus CDDP


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>S-1 | Drug: S-1<br>* S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 28 repeated 6 weeks.<br>|
| Active Comparator: 2<br>S-1 plus CDDP | Drug: S-1 plus CDDP<br>* S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 21 with a single dose of CDDP 60 mg/m2 will be administered as an 1- to 3-hour IV infusion following the morning dose of S-1 on Day 8. The combination therapy will be repeated every 5 weeks.<br>|
| Active Comparator: 3<br>5-FU plus CDDP | Drug: 5-FU plus CDDP<br>* 5-FU 600 mg/m2/24 hours administered intravenously as a CI over 120 hours (Days 1 through 5) along with a 30-minute infusion CDDP 20 mg/m2 from Day 1 through Day 5. The control treatment arm will be repeated every 4 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | every course for first three courses, then every other course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile, time to treatment failure |  | any time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stomach cancer