Study of S-1, S-1/CDDP, and 5-FU/CDDP for Advanced Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT00202969|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 7, 2011
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Response rate [ Time Frame: every course for first three courses, then every other course ]
- Safety profile, time to treatment failure [ Time Frame: any time ]
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 ClinicalTrials.gov identifier (NCT number): NCT00202969
|Beijing Cancer Hospital|
|No.52 Fu-Cheng Road, Hai-dian District, Beijing, China|
|Principal Investigator:||Jin Maolin, MD||Beijing Cancer Hospital|