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
18 Years
N/A
Both
Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction
Trial Information
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).
Inclusion Criteria:
- Has given written Informed Consent
- Histologically confirmed, unresectable, metastatic diffuse gastric cancer including
carcinoma of the gastro-esophageal junction
- No prior chemotherapy for gastric cancer except adjuvant and/or neo-adjuvant
chemotherapy more than 12 months ago
- Life expectancy of at least 3 months
- Able to take medications orally
- ECOG performance status 0 to 1
- Adequate organ function (bone marrow, kidney and liver)
Exclusion Criteria:
- Certain type(s) of non-measurable lesion(s), if the only one(s).
- Certain serious illness or medical condition(s)
- Lost greater than or equal to 10% of body weight in the 3 months proceeding signing
the ICF
- Treatment with drugs interacting with S-1, 5-FU, or cisplatin.
- Pregnant or lactating female.
- Known hypersensitivity to fluoropyrimidines or cisplatin.
Other protocol-defined inclusion/exclusion criteria may apply
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Outcome Measure: Overall survival (OS)
Outcome Time Frame:
12 months after the last patient is randomized or the target number of events is reached, whichever is later
Safety Issue:
No
Principal Investigator
Jaffer Ajani, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
TPU-S1303
NCT ID:
NCT01285557
Start Date:
February 2011
Completion Date:
August 2014
Related Keywords:
- Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction
- Gastric Cancer , S-1, Phase 3
- Carcinoma
- Esophageal Diseases
- Stomach Neoplasms
Name | Location |
|---|---|
| Fountain Valley, California 92708 | |
| Philadelphia, Pennsylvania 19104 | |
| Austin, Texas 78705 | |
| Albuquerque, New Mexico 87131-5636 | |
| Metairie, Louisiana 70006 | |
| Charleston, South Carolina |
