Trial Information

A clinical research study for patients with gastric cancer.

Diffuse Gastric and Esophagogastric junction cancer S-1 Trial

The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and esophagogastric junction cancer previously untreated with chemotherapy.

Official Title:
An Open-Label, Multicenter, Randomized, Phase 3 Study of S-1 and Cisplatin Compared with 5-FU and Cisplatin in Patients with Metastatic Diffuse Gastric Cancer Previously Untreated with Chemotherapy.

This is an open-label, international, Phase 3 study evaluating the efficacy and safety of the S-1/cisplatin regimen versus the 5-FU/cisplatin regimen in chemotherapy-naïve patients with metastatic diffuse gastric carcinoma including carcinoma of the gastro-esophageal junction. Patients will be randomly assigned to S-1/cisplatin (experimental regimen, Arm A) or 5-FU/cisplatin (control regimen, Arm B).

Study Type: Interventional
Overall Recruitment Status: Recruiting
Study Start Date: Feb 2011
Study Completion Date: August 2014
Primary Completion Date: June 2014

Phase: III

Inclusion Criteria:
1. Has given written Informed Consent
2. Histologically confirmed, unresectable, metastatic diffuse gastric cancer including carcinoma of the gastro-esophageal junction
3. No prior chemotherapy for gastric cancer except adjuvant and/or neo-adjuvant chemotherapy more than 12 months ago
4. Life expectancy of at least 3 months
5. Able to take medications orally
6. ECOG performance status 0 to 1
7. Adequate organ function (bone marrow, kidney and liver)

Exclusion Criteria:
1. Certain type(s) of non-measurable lesion(s), if the only one(s).
2. Certain serious illness or medical condition(s)
3. Lost greater than or equal to 10% of body weight in the 3 months proceeding signing the ICF
4. Treatment with drugs interacting with S-1, 5-FU, or cisplatin.
5. Pregnant or lactating female.
6. Known hypersensitivity to fluoropyrimidines or cisplatin.

Other protocol-defined inclusion/exclusion criteria may apply.

Research Site
Located in:
Ribeirão Preto 14015-130
Brazil
Phone: 1-888-292-2990 (Menu Option 0)
Email: gastricstudy@centerwatch.com

If you would like to learn more about participating in this study, please send an email message using the form below.

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