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Open Access Highly Accessed Study protocol

Fast track multi-discipline treatment (FTMDT trial) versus conventional treatment in colorectal cancer--the design of a prospective randomized controlled study

Jiao-Jiao Zhou1, Jun Li1, Xiao-Jiang Ying2, Yong-Mao Song1, Rong Chen3, Gang Chen4, Min Yan4 and Ke-Feng Ding1*

Author Affiliations

1 Department of Surgical Oncology, Second Affiliated Hospital, and The Key Laboratory of Cancer Prevention and Intervention, China National Ministry of Education, Zhejiang University College of Medicine, 88 Jie-Fang Rd, Hangzhou, Zhejiang 310009, China

2 Department of Anorectum, People's Hospital of Shaoxing, 568 Zhong-Xing North Rd, Shaoxing, Zhejiang 312000, China

3 Department of Anus and Large Intestine, Second Affiliated Hospital, Wenzhou Medicine College, 109 Xue-Yuan West Rd, Wenzhou, Zhejiang 325027, China

4 Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University College of Medicine, 88 Jie-Fang Rd, Hangzhou, Zhejiang 310009, China

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BMC Cancer 2011, 11:494  doi:10.1186/1471-2407-11-494

Published: 24 November 2011

Abstract

Background

Laparoscopy-assisted surgery, fast-track perioperative treatment are both increasingly used in colorectal cancer treatment, for their short-time benefits of enhanced recovery and short hospital stays. However, the benefits of the integration of the Laparoscopy-assisted surgery, fast-track perioperative treatment, and even with the Xelox chemotherapy, are still unknown. In this study, the three treatments integration is defined as "Fast Track Multi-Discipline Treatment Model" for colorectal cancer and this model extends the benefits to the whole treatment process of colorectal cancer. The main purpose of the study is to explore the feasibility of "Fast Track Multi-Discipline Treatment" model in treatment of colorectal cancer.

Methods

The trial is a prospective randomized controlled study with 2 × 2 balanced factorial design. Patients eligible for the study will be randomized to 4 groups: (I) Laparoscopic surgery with fast track perioperative treatment and Xelox chemotherapy; (II) Open surgery with fast track perioperative treatment and Xelox chemotherapy; (III) Laparoscopic surgery with conventional perioperative treatment and mFolfox6 chemotherapy; (IV) Open surgery with conventional perioperative treatment and mFolfox6 chemotherapy. The primary endpoint of this study is the hospital stays. The secondary endpoints are the quality of life, chemotherapy related adverse events, surgical complications and hospitalization costs. Totally, 340 patients will be enrolled with 85 patients in each group.

Conclusions

The study initiates a new treatment model "Fast Track Multi-Discipline Treatment" for colorectal cancer, and will provide feasibility evidence on the new model "Fast Track Multi-Discipline Treatment" for patients with colorectal cancer.

Trial registration

ClinicalTrials.gov: NCT01080547

Keywords:
Colorectal surgery; Rehabilitation; Colorectal neoplasms; Hospitalization; Randomized controlled trial