drugset / Trial / NCT02090153
Study of S-1 Plus LV for Advanced Gastric Cancer
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the effectiveness and safety of S-1 plus Leucovorin (1 week on and 1 week off) as first-line treatment for patients with metastatic and recurrent gastric cancer.
Timeline
- Start
- 2011-07
- Primary completion
- 2013-07
- Completion
- 2014-03
Publications
- Background Koizumi W, Boku N, Yamaguchi K, Miyata Y, Sawaki A, Kato T, Toh Y, Hyodo I, Nishina T, Furuhata T, Miyashita K, Okada Y. Phase II study of S-1 plus leucovorin in patients with metastatic colorectal cancer. Ann Oncol. 2010 Apr;21(4):766-771. doi: 10.1093/annonc/mdp371. Epub 2009 Oct 14.
- He MM, Zhang DS, Wang F, Wang ZX, Yuan SQ, Wang ZQ, Luo HY, Ren C, Qiu MZ, Jin Y, Wang DS, Chen DL, Zeng ZL, Li YH, He YY, Hao YT, Guo P, Wang FH, Zeng YX, Xu RH. Phase II trial of S-1 plus leucovorin in patients with advanced gastric cancer and clinical prediction by S-1 pharmacogenetic pathway. Cancer Chemother Pharmacol. 2017 Jan;79(1):69-79. doi: 10.1007/s00280-016-3209-1. Epub 2016 Dec 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LV [arm: experimental] — LV is given simultaneously at a fixed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest. | Unknown | 25 mg | Oral |
| Subject | S-1 | Small molecule | 40 mg | Oral |
| Subject | S-1 | Small molecule | 50 mg | Oral |
| Subject | S-1 | Small molecule | 60 mg | Oral |