XParTS II: Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer
|ClinicalTrials.gov Identifier: NCT01406249|
Recruitment Status : Unknown
Verified July 2017 by Epidemiological and Clinical Research Information Network.
Recruitment status was: Active, not recruiting
First Posted : August 1, 2011
Last Update Posted : July 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: SP Drug: XP||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Trial Comparing Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer (XParTS II)|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
|Active Comparator: S-1,Cisplatin||
S-1 will be administered at 40 mg/m2 orally, twice daily (80 mg/m2 total daily dose) on Days 1 through 21 of each 35-day treatment cycle.
Cisplatin will be administered at 60 mg/m2 by intravenous infusion on Day 8 of each 35-day treatment cycle.
|Experimental: Capecitabine, Cisplatin||
Capecitabine will be administered at 1,000 mg/m2 orally, twice daily (2,000 mg/m2 total daily dose) on Days 1 through 14 of each 21-day treatment cycle.
Cisplatin will be administered at 80 mg/m2 by intravenous infusion on Day 1 of each 21-day treatment cycle.
- Progression-free survival rate [ Time Frame: at 24weeks from patient enrollment ]
- Time-to treatment failure [ Time Frame: 3year ]
- Response rate [ Time Frame: 3 year ]
- Overall survival [ Time Frame: 3 year ]
- Safety [ Time Frame: 3 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406249
|Epidemiological and Clinical Research Information Network|
|Kyoto, Japan, 606-8392|
|Principal Investigator:||Akira Tsuburaya||Shonan Kamakura Hospital|