Study of S-1, S-1/CDDP, and 5-FU/CDDP for Advanced Gastric Cancer
Information source: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastric Cancer
Intervention: S-1 (Drug); S-1 plus CDDP (Drug); 5-FU plus CDDP (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Taiho Pharmaceutical Co., Ltd. Official(s) and/or principal investigator(s): Jin Maolin, MD, Principal Investigator, Affiliation: Beijing Cancer Hospital
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Response rate
Secondary outcome: Safety profile, time to treatment failure
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Beijing Cancer Hospital, No.52 Fu-Cheng Road, Hai-dian District, Beijing, China
Additional Information
Starting date: July 2005
Last updated: July 6, 2011
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