Research Papers:

Interim analysis of postoperative chemoradiotherapy with capecitabine and oxaliplatin versus capecitabine alone for pathological stage II and III rectal cancer: a randomized multicenter phase III trial

Yan-Ru Feng _, Yuan Zhu, Lu-Ying Liu, Wei-Hu Wang, Shu-Lian Wang, Yong-Wen Song, Xin Wang, Yuan Tang, Yue-Ping Liu, Hua Ren, Hui Fang, Shi-Ping Zhang, Xin-Fan Liu, Zi-Hao Yu, Ye-Xiong Li and Jing Jin

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Oncotarget. 2016; 7:25576-25584. https://doi.org/10.18632/oncotarget.8226

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Yan-Ru Feng1, Yuan Zhu2, Lu-Ying Liu2, Wei-Hu Wang1, Shu-Lian Wang1, Yong-Wen Song1, Xin Wang1, Yuan Tang1, Yue-Ping Liu1, Hua Ren1, Hui Fang1, Shi-Ping Zhang1, Xin-Fan Liu1, Zi-Hao Yu1, Ye-Xiong Li1, Jing Jin1

1Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China

2Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou, China

Correspondence to:

Ye-Xiong Li, e-mail: [email protected]

Jing Jin, e-mail: [email protected]

Keywords: rectal cancer, postoperative chemoradiotherapy, capecitabine, oxaliplatin, phase 3 trial

Received: November 15, 2015    Accepted: March 04, 2016    Published: March 21, 2016


The aim of this study is to present an interim analysis of a phase III trial (NCT00714077) of postoperative concurrent capecitabine and radiotherapy with or without oxaliplatin for pathological stage II and III rectal cancer. Patients with pathologically confirmed stage II and III rectal cancer were randomized to either radiotherapy with concurrent capecitabine (Cap-RT group) or with capecitabine and oxaliplatin (Capox-RT group). The primary endpoint was 3-year disease-free survival rate (DFS). The 3-year DFS rate was 73.9% in the Capox-RT group and 71.6% in the Cap-RT group (HR 0.92, p = 0.647), respectively. No significant difference was observed in overall survival, cumulative incidence of local recurrence and distant metastasis between the two groups (p > 0.05). More grade 3–4 acute toxicity was observed in the Capox-RT group than in the Cap-RT group (38.1% vs. 29.2%, p = 0.041). Inclusion of oxaliplatin in the capecitabine-based postoperative regimen did not improve DFS but increased toxicities for pathological stage II and III rectal cancer in this interim analysis.

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