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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00202969
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 7, 2011
Information provided by:
Taiho Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: S-1 Drug: S-1 plus CDDP Drug: 5-FU plus CDDP Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: S-1
S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 28 repeated 6 weeks.
Active Comparator: 2
S-1 plus CDDP
Drug: S-1 plus CDDP
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.
Active Comparator: 3
5-FU plus CDDP
Drug: 5-FU plus CDDP
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.

Primary Outcome Measures :
  1. Response rate [ Time Frame: every course for first three courses, then every other course ]

Secondary Outcome Measures :
  1. Safety profile, time to treatment failure [ Time Frame: any time ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00202969

China, Beijing
Beijing Cancer Hospital
No.52 Fu-Cheng Road, Hai-dian District, Beijing, China
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Principal Investigator: Jin Maolin, MD Beijing Cancer Hospital

Responsible Party: Taiho Pharmaceutical Co., Ltd. Identifier: NCT00202969     History of Changes
Other Study ID Numbers: SC101
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: July 7, 2011
Last Verified: July 2011

Keywords provided by Taiho Pharmaceutical Co., Ltd.:
Stomach cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents