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- Title
A phase I trial of S-1 with concurrent radiotherapy in patients with locally recurrent rectal cancer.
- Authors
Wada, Hitoshi; Nemoto, Kenji; Nomiya, Takuma; Murakami, Misako; Suzuki, Motohisa; Kuroda, Yuuki; Ichikawa, Mayumi; Ota, Ibuki; Hagiwara, Yasuhito; Ariga, Hisanori; Takeda, Ken; Takai, Kenji; Fujimoto, Keisuke; Kenjo, Masahiro; Ogawa, Kazuhiko
- Abstract
Background: The purpose of this phase I trial of S-1 chemotherapy in combination with pelvic radiotherapy for locally recurrent rectal cancer was to determine the maximum tolerated dose (MTD), recommended dose (RD), and dose-limiting toxicity (DLT) of S-1. Methods: We enrolled 9 patients between April 2005 and March 2009. Radiotherapy (total dose, 60 Gy in 30 fractions) was given to the gross local recurrent tumor and pelvic nodal metastases using three-dimensional radiotherapy planning. We administered oral S-1 twice a day on days 1-14 and 22-35 during radiotherapy. The dose of S-1 was initially 60 mg/m/day and was increased to determine the MTD and RD for this regimen. Results: DLT appeared at dose level 2 (70 mg/m/day) in 2 patients, who experienced grade 3 enterocolitis and consequently required suspension of S-1 administration for longer than 2 weeks. Hematological toxicity was mild and reversible. At the initial evaluation, complete regression and partial regression were seen in 1 patient (11%) and 2 patients (22%), respectively. Conclusion: This phase I trial of S-1 chemotherapy with pelvic radiotherapy for locally recurrent rectal cancer revealed that the MTD for S-1 was 70 mg/m/day and the RD was 60 mg/m/day.
- Subjects
CANCER radiotherapy; CLINICAL trials; RECTAL cancer; CANCER relapse; CANCER chemotherapy; HEMATOLOGICAL oncology
- Publication
International Journal of Clinical Oncology, 2013, Vol 18, Issue 2, p273
- ISSN
1341-9625
- Publication type
Article
- DOI
10.1007/s10147-012-0375-y