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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


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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 20, 2015

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