Back to resultsStudy of S-1, S-1/CDDP, and 5-FU/CDDP for Advanced Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
S-1
S-1 plus CDDP
5-FU plus CDDP
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Stomach cancer
Eligibility 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
Sites / Locations
- Beijing Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
S-1
S-1 plus CDDP
5-FU plus CDDP
Outcomes
Primary Outcome Measures
Response rate
Secondary Outcome Measures
Safety profile, time to treatment failure
Full Information
NCT ID
NCT00202969
First Posted
September 12, 2005
Last Updated
July 6, 2011
Sponsor
Taiho Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00202969
Brief Title
Study of S-1, S-1/CDDP, and 5-FU/CDDP for Advanced Gastric Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Taiho Pharmaceutical Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Stomach cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
S-1
Arm Title
2
Arm Type
Active Comparator
Arm Description
S-1 plus CDDP
Arm Title
3
Arm Type
Active Comparator
Arm Description
5-FU plus CDDP
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 28 repeated 6 weeks.
Intervention Type
Drug
Intervention Name(s)
S-1 plus CDDP
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
5-FU plus CDDP
Intervention Description
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 Measure Information:
Title
Response rate
Time Frame
every course for first three courses, then every other course
Secondary Outcome Measure Information:
Title
Safety profile, time to treatment failure
Time Frame
any time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Maolin, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
No.52 Fu-Cheng Road, Hai-dian District
State/Province
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study of S-1, S-1/CDDP, and 5-FU/CDDP for Advanced Gastric Cancer
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