Zhou et al. BMC Cancer 2011, 11:494 http://www.biomedcentral.com/1471-2407/11/494 Background Achieving a better quality of life for patients through enhanced recovery and shorter hospital stays in colorec- tal cancer treatment is becoming increasingly important. Compared with open surgery, laparoscopy-assisted surgery has been proved by consistent evidence as a safe and effective method of colorectal cancer treatment. It also has demonstrated the benefits in reduction of surgi- cal injury and the improvement of short-term recovery outcome [1-4]. Fast-track perioperative treatment, which is also referred as Enhanced Recovery after Surgery (ERAS), attracted much attention since Henrik Kehlet initially raised this concept [5]. This evidence-based fast-track perioperative treatment has been used for nearly a dec- ade. The principle of the Fast-track treatment is to gain faster and enhanced recovery after surgery, by reducing unnecessary interventions which were for- mally involved in perioperative treatment, like reducing the fasting periods and bed rest time. Since the first time Henrik Kehlet prompted the notion, many studies have confirmed the advantages of the Fast-track treat- ment, especially the advantages of accelerating the short-term recovery, reducing the postoperative mor- bidity, shortening the hospital stays and improving the life quality [6-14]. Nevertheless, most recent researches into laparoscopy and Fast-track treatment of colorectal cancer focus on the perioperative care, which are much more related to short-term benefits, last only 1-2 weeks perioperative. In contrast, adjuvant chemotherapy takes up around 6 months of the whole colorectal cancer treatment, but has been neglected in researches mentioned above at present. So, the thoughts of combining the laparoscopy, Fast-track perioperative treatment and adjuvant che- motherapy naturally rise up, in the attempt to gain the maximum benefits covering both short-term and long- term. Xelox and mFolfox6 chemotherapy are currently used as two comparable effective adjuvant chemotherapies for colorectal cancer, and Xelox chemotherapy is already being widely used in colorectal cancer, as it has better manageable tolerability and similar Overall Survival(OS) [15-17] versus mFolfox6 chemotherapy. Until now, there has been no published study researching the effects of the combination of laparo- scopy, Fast-track treatment and Xelox chemotherapy, which has been focused on in this FTMDT (Fast Track Multi-Discipline Treatment) trial. And we propose the new model “Fast Track Multi-Discipline Treatment” for this combination. In view of the improved rehabilitation the three component parts bring to the colorectal cancer treatment, we aim to find a more economical and Page 2 of 10 effective mode for colorectal cancer treatment through this prospective randomized controlled FTMDT-trial study. Since it has not been established whether FTMDT is superior to conventional treatment (open or laparo- scopic surgery with conventional perioperative treatment and mFolfox6 chemotherapy) in colorectal cancer treat- ment, the following is the present study protocol. Methods/Design Study objectives The general objective of this FTMDT trial is to assess, synthesize and discuss the feasibility of “Fast Track Multi-Discipline Treatment” model in treatment of col- orectal cancer. It can be divided into 2 questions: 1. Is it safe and effective to combine Xelox chemotherapy with laparoscopy and fast-track perioperative treatment? 2. Is laparoscopy an essential component of FTMDT and how important a role does it play? Study design This FTMDT-trial is an open randomized prospective and controlled study with 2 × 2 balanced factorial design. Patients eligible for the criteria will be rando- mized into four study groups (1:1:1:1) according to the randomized figures generated by the SPSS 16.0, after the patients signing the informed consents: (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 sur- gery with conventional perioperative treatment and mFolfox6 chemotherapy. Chinese medical insurance system ensures that, hospi- talization is suitable for payment and also for patients’ interest. All patients in this study will receive hospita- lized chemotherapy in each cycle. This trial has the independent “third-party” for devel- oping the randomization. Eligibility Inclusion Criteria: patients who are 18 years and older, with pathologically confirmed colon and upper rectal cancer and signed informed consent prior to enrollment. Exclusion Criteria: Tumors which can be resected by endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), history of malignancy, bowel obstruction or intestinal perforation, evidence of metastasis through physical examination, chest roent- genogram and computed tomography of liver and pelvis, acute disease and acute attack of chronic disease, psy- chiatric history, spinal deformity, American Society of