NCT01412294

XParTS: Capecitabine/Cisplatin(XP) for Recurrent Gastric Cancer

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Epidemiological and Clinical Research Information Network · Academic / Other
• Sex: All
• Age: 20 Weeks – 74 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-07-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2011-08-09
• Last updated: 2017-07-27

Locations

1 site across 1 country: Japan