Phase II trial of neoadjuvant chemotherapy with XELOX plus bevacizumab for locally advanced rectal cancer

Keisuke Uehara, Seiji Ishiguro, Eiji Sakamoto, Atsuyuki Maeda, Masaya Inoue, Yuichiro Tojima, Satoshi Kobayashi, Naoki Omiya, Naoki Ishizuka, Akimasa Nakao, Hidemi Goto, Masato Nagino

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Abstract

In Western countries, the standard treatment for locally advanced rectal cancer is preoperative chemoradiotherapy followed by total mesorectal excision. On the other hand, in Japan, treatment results without radiotherapy are by no means inferior; therefore, extrapolation of results of preoperative treatment in Western countries to Japan is controversial. We consider that survival may be improved by preoperative treatment 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 chemotherapy using XELOX plus bevacizumab without radiotherapy in patients with locally advanced rectal cancer. The primary endpoint of the study is treatment compliance. Secondary endpoints are overall survival, disease-free survival, local recurrence-free survival, objective response rate, R0 resection rate and adverse events. Thirty patients are required for this study.

Original languageEnglish
Article numberhyr084
Pages (from-to)1041-1044
Number of pages4
JournalJapanese journal of clinical oncology
Volume41
Issue number8
DOIs
Publication statusPublished - 01-08-2011

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All Science Journal Classification (ASJC) codes

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

Uehara, K., Ishiguro, S., Sakamoto, E., Maeda, A., Inoue, M., Tojima, Y., Kobayashi, S., Omiya, N., Ishizuka, N., Nakao, A., Goto, H., & Nagino, M. (2011). Phase II trial of neoadjuvant chemotherapy with XELOX plus bevacizumab for locally advanced rectal cancer. Japanese journal of clinical oncology, 41(8), 1041-1044. [hyr084]. https://doi.org/10.1093/jjco/hyr084