Study Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer
Randomized Controlled Trial Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer
1 other identifier
interventional
374
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2010
Longer than P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedFirst Posted
Study publicly available on registry
March 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedApril 6, 2017
December 1, 2016
4.1 years
March 1, 2010
April 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
hospitalization day
The overall hospitalization stay during treatment from the first day in hospital to leave hospital when finish adjuvant chemotherapy or surgery (for patients who don't need chemotherapy).
6-month post surgery
Secondary Outcomes (4)
surgical complications
3-month post surgery
chemotherapy related adverse event
6-month post surgery
quality of life
preoperation, 3-month post surgery and 6-month post surgery
hospitalization costs
6-month post surgery
Study Arms (4)
Conventional Treatment （Laparoscopic）
ACTIVE COMPARATORRandomized group of patients receiving laparoscopic colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
FTMD Treatment （Laparoscopic）
ACTIVE COMPARATORRandomized group of patients receiving laparoscopic colectomy with Fast Track Multi-Displine（FTMD）treatment and XELOX chemotherapy.
Conventional Treatment（Open Surgery）
ACTIVE COMPARATORRandomized group of patients receiving open colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
FTMD Treatment（Open Surgery）
ACTIVE COMPARATORRandomized group of patients receiving open colectomy with Fast Track Multi-Displine（FTMD） treatment and XELOX chemotherapy.
Interventions
Laparoscopic surgery for colorectal cancer using STORZ laparoscope
XELOX chemotherapy
Conventional (mFolfox6) chemotherapy
Fast track treatment during perioperation period
Conventional treatment during perioperation period
Open surgery for colorectal cancer using conventional methods
Eligibility Criteria
You may qualify if:
- Patients with pathologically confirmed colorectal cancer
- Signed consent
You may not qualify if:
- Tumor can be resected by endoscopic mucosal resection(EMR)
- History of malignancy
- Bowel obstruction or intestinal perforation
- Evidence of metastasis by physical examination, chest roentgenogram and computed tomography of liver and pelvis
- Acute diseases and acute attack of chronic diseases
- Psychiatric history
- Deformity of spine
- ASA score≥Ⅳ
- Mid-low rectal cancer
- Pregnant woman
- Needing to use Chinese traditional patent drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Second Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, Zhejiang, 310999, China
People's Hospital of Shaoxing
Shaoxing, Zhejiang, 312000, China
Related Publications (3)
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.
PMID: 31647032DERIVEDXu 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.
PMID: 25649903DERIVEDZhou 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.
PMID: 22111914DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ke-Feng Ding, PhD/MD
The Second Affiliated Hospital, and The Key Laboratory of Cancer Prevention and Intervention, China National Ministry of Education, Zhejiang University College of Medicine.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of SAHZU
Study Record Dates
First Submitted
March 1, 2010
First Posted
March 4, 2010
Study Start
March 1, 2010
Primary Completion
April 1, 2014
Study Completion
December 1, 2014
Last Updated
April 6, 2017
Record last verified: 2016-12