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Motohiro Imano, Hiroshi Furukawa, Masaki Yokokawa, Yasumasa Nishimura, Yukinori Kurokawa, Taroh Satoh, Daisuke Sakai, Takushi Yasuda, Haruhiko Imamoto, Toshimasa Tujinaka, Toshio Shimokawa, Hitoshi Shiozaki, (The Osaka Gastrointestinal Cancer Chemotherapy Study Group), A Phase I/II Trial of Radiotherapy Concurrent with TS-1 Plus Cisplatin in Patients with Clinically Resectable Type 4 or Large Type 3 Gastric Cancer: Osaka Gastrointestinal Cancer Chemotherapy Study Group OGSG1205, Japanese Journal of Clinical Oncology, Volume 43, Issue 4, April 2013, Pages 431–435, https://doi.org/10.1093/jjco/hys239
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Abstract
A Phase I/II trial of radiotherapy administered concurrently with TS-1 plus cisplatin has been initiated in Japanese patients with clinical resectable type 4 or large type 3 gastric cancer. The aim of this trial is to determine the recommended dose of TS-1 and cisplatin combined with radiotherapy at a fixed dose in the Phase I study, and to evaluate the efficacy and safety in the Phase II study. The primary endpoint for Phase II is the pathological complete response rate, assessed using surgically resected specimens. Secondary endpoints are the response rate, progression-free survival, overall survival, operation transitional rate, R0 resection rate, rate of treatment completion, rate of down-staging and rates of postoperative complications and adverse events. In Phase II, a total of 30 patients will be enrolled in the Osaka Gastrointestinal Cancer Chemotherapy Study Group trial over a period of 6 years.
- radiation therapy
- select the dosage, dosage form or route of administration
- chemotherapy regimen
- cisplatin
- postoperative complications
- gastric cancer
- gastrointestinal cancer
- phase 1 clinical trials
- phase 2 clinical trials
- safety
- surrogate endpoints
- adverse event
- complete remission
- japanese
- progression-free survival