A Phase I/II trial of chemoradiotherapy concurrent with S-1 plus mitomycin C in patients with clinical Stage II/III squamous cell carcinoma of anal canal (JCOG0903: SMART-AC).

Abstract:

:A Phase I/II trial of chemoradiotherapy concurrent with S-1 plus mitomycin C in patients with clinical Stage II/III squamous cell carcinoma of the anal canal was started in Japan. The aim of this trial is to determine the recommended dose of S-1 combined with a fixed dose of mitomycin C plus radiotherapy in Phase I and to evaluate the efficacy and safety in Phase II. The primary endpoint for the Phase II part of this study is the proportion of 3-year event-free survival, in which the following are defined as events: disease progression, residual tumor at the end of chemoradiotherapy, colostomy or death, whichever comes first. Secondary endpoints are progression-free survival, proportion of complete response and adverse events. In the Phase II part of this study, a total of 65 patients will be enrolled from 42 institutions over 6 years.

journal_name

Jpn J Clin Oncol

authors

Takashima A,Shimada Y,Hamaguchi T,Ito Y,Nakano A,Nakamura K,Shibata T,Fukuda H,Moriya Y,Colorectal Cancer Study Group of the Japan Clinical Oncology Group.

doi

10.1093/jjco/hyr028

subject

Has Abstract

pub_date

2011-05-01 00:00:00

pages

713-7

issue

5

eissn

0368-2811

issn

1465-3621

pii

hyr028

journal_volume

41

pub_type

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