XParTS: Capecitabine/Cisplatin(XP) for Recurrent Gastric Cancer
The aim of this study is to evaluate efficacy and safety of Capecitabine/Cisplatin for gastric cancer patients who relapsed after adjuvant chemotherapy by S-1.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study to Evaluate Efficacy and Safety of Capecitabine/Cisplatin Combination Therapy in Gastric Cancer Patients Who Relapsed After S-1 Adjuvant Chemotherapy (XParTS)|
- Progression-free survival [ Time Frame: 2 year ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 2 year ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: 2 year ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: 2 year ] [ Designated as safety issue: No ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Experimental: Capecitabine, Cisplatin||
Drug: Capecitabine, Cisplatin
Drug: Capecitabine 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.
Drug: Cisplatin Cisplatin will be administered at 80 mg/m2 by intravenous infusion on Day 1 of each 21-day treatment cycle.
S-1/Cisplatin (SP) is one of the standard treatments of advanced gastric cancer. However, evidence of SP on gastric cancer recurrence after adjuvant therapy by the same drug (S-1) is not established. The aim of this study is to evaluate the efficacy and safety of Capecitabine/Cisplatin (XP) for gastric cancer patients who relapsed after adjuvant chemotherapy by S-1.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412294
|Contact: Junichi Sakamotofirstname.lastname@example.org|
|Epidemiological and Clinical Research Information Network||Recruiting|
|Kyoto, Japan, 606-8392|
|Principal Investigator: Akira Tsuburaya|
|Principal Investigator:||Akira Tsuburaya||Shonan Kamakura Hospital|