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

Phase 2 Unknown 40 enrolled Epidemiological and Clinical Research Information Network

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2011-07
Primary completion: 2017-12
Completion: 2017-12

Outcome

Met primary endpoint

paper Median PFS was 4.4 months (95% CI 3.6-5.1), which was longer than the 2-month protocol-specified threshold (p < 0.001). PMID 29488122 ↗

Publications

Nishikawa K, Tsuburaya A, Yoshikawa T, Takahashi M, Tanabe K, Yamaguchi K, Yoshino S, Namikawa T, Aoyama T, Rino Y, Kawada J, Tsuji A, Taira K, Kimura Y, Kodera Y, Hirashima Y, Yabusaki H, Hirabayashi N, Fujitani K, Miyashita Y, Morita S, Sakamoto J. A phase II trial of capecitabine plus cisplatin (XP) for patients with advanced gastric cancer with early relapse after S-1 adjuvant therapy: XParTS-I trial. Gastric Cancer. 2018 Sep;21(5):811-818. doi: 10.1007/s10120-018-0815-0. Epub 2018 Feb 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	1000 mg/m2	Oral
Subject	Cisplatin	Other / unclassified	80 mg/m2	Intravenous