Clinical trial NCT01080547: Study Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer
Official title: Randomized Controlled Trial Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Length of Stay
Complications
Adverse Drug Event
Quality of Life
Hospital Costs
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2010-03-04
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A new notion"Fast Track Multi-Discipline Treatment" for colorectal cancer is thought with several benefits such as shorter hospitalization stay and less costs. This randomized study aims to compare the differences between conventional and Fast Track Multi-Discipline Treatment for colorectal cancer in hospitalization day, complications, costs and quality of life.

Detailed description: Laparoscopic Surgery, Fast Track Treatment and XELOX Chemotherapy have been introduced in the treatment of colorectal cancer. All of these procedures are contributed to reduce the hospitalization stay. However, the most economical mode for combination of these procedures is still unclear. This is a randomized controlled study, a new notion"Fast Track Multi-Discipline Treatment" is proposed, which is the combination of the Laparoscopic Surgery, Fast track perioperative treatment during perioperative period and XELOX Chemotherapy. The purpose of this study is to compare the Fast Track Multi-Discipline Treatment with the conventional treatment(Open Surgery with conventional treatment during perioperative period and mFolfox6 chemotherapy) for colorectal cancer on several aspects like the average hospitalization day, complications, costs and quality of life.The focus of the study will be to investigate whether the Fast Track Multi-Discipline Treatment reduces hospital stay with similar complications compared with conventional perioperative treatment. Moreover, the trial will clarify whether laparoscopic surgery is essential for Fast Track Multi-Discipline Treatment.

Eligibility criteria: Inclusion Criteria:

1. Patients with pathologically confirmed colorectal cancer
2. Signed consent

Exclusion Criteria:

1. Tumor can be resected by endoscopic mucosal resection(EMR)
2. History of malignancy
3. Bowel obstruction or intestinal perforation
4. Evidence of metastasis by physical examination, chest roentgenogram and computed tomography of liver and pelvis
5. Acute diseases and acute attack of chronic diseases
6. Psychiatric history
7. Deformity of spine
8. ASA score≥Ⅳ
9. Mid-low rectal cancer
10. Pregnant woman
11. Needing to use Chinese traditional patent drug

Primary outcomes:
measure: hospitalization day
timeFrame: 6-month post surgery
Secondary outcomes:
measure: surgical complications
timeFrame: 3-month post surgery
measure: chemotherapy related adverse event
timeFrame: 6-month post surgery
measure: quality of life
timeFrame: preoperation, 3-month post surgery and 6-month post surgery
measure: hospitalization costs
timeFrame: 6-month post surgery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital Zhejiang University College of Medicine
state: Zhejiang
city: Shaoxing
country: China
facility: People's Hospital of Shaoxing
state: Zhejiang
Study officials:
affiliation: The Second Affiliated Hospital, and The Key Laboratory of Cancer Prevention and Intervention, China National Ministry of Education, Zhejiang University College of Medicine.
name: Ke-Feng Ding, PhD/MD
role: STUDY_CHAIR
References:
citation: Li J, Kong XX, Zhou JJ, Song YM, Huang XF, Li GH, Ying XJ, Dai XY, Lu M, Jiang K, Fu DL, Li XL, He JJ, Wang JW, Sun LF, Xu D, Xu JY, Chen M, Tian Y, Li JS, Yan M, Yuan Y, Ding KF. Fast-track multidisciplinary treatment versus conventional treatment for colorectal cancer: a multicenter, open-label randomized controlled study. BMC Cancer. 2019 Oct 23;19(1):988. doi: 10.1186/s12885-019-6188-x.
citation: Xu D, Li J, Song Y, Zhou J, Sun F, Wang J, Duan Y, Hu Y, Liu Y, Wang X, Sun L, Wu L, Ding K. Laparoscopic surgery contributes more to nutritional and immunologic recovery than fast-track care in colorectal cancer. World J Surg Oncol. 2015 Feb 4;13:18. doi: 10.1186/s12957-015-0445-5.
citation: Zhou JJ, Li J, Ying XJ, Song YM, Chen R, Chen G, Yan M, Ding KF. Fast track multi-discipline treatment (FTMDT trial) versus conventional treatment in colorectal cancer--the design of a prospective randomized controlled study. BMC Cancer. 2011 Nov 24;11:494. doi: 10.1186/1471-2407-11-494.