CapeOX perioperative chemotherapy versus postoperative chemotherapy for locally advanced resectable colon cancer: Protocol for a two-period randomised controlled phase III trial

Fangqi Liu, Tong Tong, Dan Huang, Weitang Yuan, Dechuan Li, Jianjiang Lin, Sanjun Cai, Ye Xu, Wenbin Chen, Yueming Sun, Jing Zhuang

Research output: Contribution to journalArticle

Abstract

Introduction Adjuvant chemotherapy with the CapeOX regimen is now widely used for treating colorectal cancer. However, prior studies have demonstrated better efficacy of pre-operative/neoadjuvant chemotherapy without increase of safety risks. Methods and Analysis This multicentre, open-label, parallel-group, randomised, controlled, phase III study aims to compare the efficacy and safety of perioperative CapeOX chemotherapy with the postoperative one for treating patients with locally advanced R0 resectable colon cancers in China. In total 1370 eligible patients will be randomised to: the test group, up to four cycles (every 3 weeks is a cycle, Q3W) of chemotherapy plus radical surgery plus up to four cycles of post-operative chemotherapy; or the control group, radical surgery first, then up to eight cycles of chemotherapy. In each cycle, oxaliplatin will be given at a dose of 130 mg/m 2 through continuous IV infusion for 2 hours on the first day. From day 1 to day 14, capecitabine will be taken orally every morning and evening at a dose of 1000mg/m 2 /d. The primary outcome measure is the 3-year disease free survival. The objective response rate, R0 resection rate, overall survival, as well as the adverse events will also be measured as second endpoints. The study may include two periods. If results of period 1 are not favourable, period 2 will be initiated, recruiting genetically sensitive patients and repeating the same process with period 1. Ethics and dissemination Informed consent will be required from, and provided, by all subjects. The study protocol has been approved by the independent ethics committee of Shanghai Fudan University Cancer Centre. This study will clearly demonstrate the potential benefit of perioperative chemotherapy with the CapeOX regimen. Results will be shared among all the participating centres, and with policymakers and the academic community to promote the clinical management of colon cancer. Trial registration number NCT03125980.

Original languageEnglish (US)
Article numbere017637
JournalBMJ open
Volume9
Issue number1
DOIs
StatePublished - Jan 1 2019

Fingerprint

Colonic Neoplasms
Drug Therapy
oxaliplatin
Safety
Ethics Committees
Adjuvant Chemotherapy
Informed Consent
Ethics
Disease-Free Survival
Colorectal Neoplasms
China
Survival Rate
Outcome Assessment (Health Care)
Control Groups
Neoplasms

Keywords

  • capox
  • colon cancer
  • neoadjuvant chemotherapy
  • perioperative chemotherapy
  • randomized controlled trial

ASJC Scopus subject areas

  • Medicine(all)

Cite this

CapeOX perioperative chemotherapy versus postoperative chemotherapy for locally advanced resectable colon cancer : Protocol for a two-period randomised controlled phase III trial. / Liu, Fangqi; Tong, Tong; Huang, Dan; Yuan, Weitang; Li, Dechuan; Lin, Jianjiang; Cai, Sanjun; Xu, Ye; Chen, Wenbin; Sun, Yueming; Zhuang, Jing.

In: BMJ open, Vol. 9, No. 1, e017637, 01.01.2019.

Research output: Contribution to journalArticle

Liu, Fangqi ; Tong, Tong ; Huang, Dan ; Yuan, Weitang ; Li, Dechuan ; Lin, Jianjiang ; Cai, Sanjun ; Xu, Ye ; Chen, Wenbin ; Sun, Yueming ; Zhuang, Jing. / CapeOX perioperative chemotherapy versus postoperative chemotherapy for locally advanced resectable colon cancer : Protocol for a two-period randomised controlled phase III trial. In: BMJ open. 2019 ; Vol. 9, No. 1.
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T2 - Protocol for a two-period randomised controlled phase III trial

AU - Liu, Fangqi

AU - Tong, Tong

AU - Huang, Dan

AU - Yuan, Weitang

AU - Li, Dechuan

AU - Lin, Jianjiang

AU - Cai, Sanjun

AU - Xu, Ye

AU - Chen, Wenbin

AU - Sun, Yueming

AU - Zhuang, Jing

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N2 - Introduction Adjuvant chemotherapy with the CapeOX regimen is now widely used for treating colorectal cancer. However, prior studies have demonstrated better efficacy of pre-operative/neoadjuvant chemotherapy without increase of safety risks. Methods and Analysis This multicentre, open-label, parallel-group, randomised, controlled, phase III study aims to compare the efficacy and safety of perioperative CapeOX chemotherapy with the postoperative one for treating patients with locally advanced R0 resectable colon cancers in China. In total 1370 eligible patients will be randomised to: the test group, up to four cycles (every 3 weeks is a cycle, Q3W) of chemotherapy plus radical surgery plus up to four cycles of post-operative chemotherapy; or the control group, radical surgery first, then up to eight cycles of chemotherapy. In each cycle, oxaliplatin will be given at a dose of 130 mg/m 2 through continuous IV infusion for 2 hours on the first day. From day 1 to day 14, capecitabine will be taken orally every morning and evening at a dose of 1000mg/m 2 /d. The primary outcome measure is the 3-year disease free survival. The objective response rate, R0 resection rate, overall survival, as well as the adverse events will also be measured as second endpoints. The study may include two periods. If results of period 1 are not favourable, period 2 will be initiated, recruiting genetically sensitive patients and repeating the same process with period 1. Ethics and dissemination Informed consent will be required from, and provided, by all subjects. The study protocol has been approved by the independent ethics committee of Shanghai Fudan University Cancer Centre. This study will clearly demonstrate the potential benefit of perioperative chemotherapy with the CapeOX regimen. Results will be shared among all the participating centres, and with policymakers and the academic community to promote the clinical management of colon cancer. Trial registration number NCT03125980.

AB - Introduction Adjuvant chemotherapy with the CapeOX regimen is now widely used for treating colorectal cancer. However, prior studies have demonstrated better efficacy of pre-operative/neoadjuvant chemotherapy without increase of safety risks. Methods and Analysis This multicentre, open-label, parallel-group, randomised, controlled, phase III study aims to compare the efficacy and safety of perioperative CapeOX chemotherapy with the postoperative one for treating patients with locally advanced R0 resectable colon cancers in China. In total 1370 eligible patients will be randomised to: the test group, up to four cycles (every 3 weeks is a cycle, Q3W) of chemotherapy plus radical surgery plus up to four cycles of post-operative chemotherapy; or the control group, radical surgery first, then up to eight cycles of chemotherapy. In each cycle, oxaliplatin will be given at a dose of 130 mg/m 2 through continuous IV infusion for 2 hours on the first day. From day 1 to day 14, capecitabine will be taken orally every morning and evening at a dose of 1000mg/m 2 /d. The primary outcome measure is the 3-year disease free survival. The objective response rate, R0 resection rate, overall survival, as well as the adverse events will also be measured as second endpoints. The study may include two periods. If results of period 1 are not favourable, period 2 will be initiated, recruiting genetically sensitive patients and repeating the same process with period 1. Ethics and dissemination Informed consent will be required from, and provided, by all subjects. The study protocol has been approved by the independent ethics committee of Shanghai Fudan University Cancer Centre. This study will clearly demonstrate the potential benefit of perioperative chemotherapy with the CapeOX regimen. Results will be shared among all the participating centres, and with policymakers and the academic community to promote the clinical management of colon cancer. Trial registration number NCT03125980.

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