Prospective feasibility study to evaluate neoadjuvant-synchronous S-1 + RT for locally advanced rectal cancer: a multicenter phase II trial (UMIN ID: 03396)

Jpn J Clin Oncol. 2013 Mar;43(3):321-3. doi: 10.1093/jjco/hys219. Epub 2012 Dec 28.

Abstract

In Western countries, the standard treatment for locally advanced rectal cancer is preoperative chemoradiotherapy followed by total mesorectal excision. However, in Japan, the treatment results without preoperative chemoradiotherapy are by no means inferior; therefore, extrapolation of the results of preoperative treatment in Western countries to Japan is controversial. We consider that survival may be improved by preoperative chemoradiotherapy with new anticancer agents as they are expected not only to decrease the local recurrence rate but also to prevent distant metastases. We are conducting a multicentre Phase II study to evaluate the safety and efficacy of neoadjuvant chemoradiotherapy using S-1 in patients with locally advanced rectal cancer. The primary endpoint is the rate of complete treatment of neoadjuvant chemoradiotherapy. Secondary endpoints are the response rate of neoadjuvant chemoradiotherapy, short-term clinical outcomes, rate of curative resection and pathological evaluation. The short-term clinical outcomes are adverse events of neoadjuvant chemoradiotherapy and surgery-related complications. Thirty-five patients are required for this study.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antimetabolites, Antineoplastic / therapeutic use*
  • Chemoradiotherapy*
  • Clinical Protocols*
  • Drug Combinations
  • Feasibility Studies
  • Humans
  • Neoadjuvant Therapy / methods
  • Oxonic Acid / therapeutic use*
  • Rectal Neoplasms / therapy*
  • Tegafur / therapeutic use*

Substances

  • Antimetabolites, Antineoplastic
  • Drug Combinations
  • S 1 (combination)
  • Tegafur
  • Oxonic Acid