NCT01080547

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 374 (actual)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Length of Stay
• Complications
• Adverse Drug Event
• Quality of Life
• Hospital Costs

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic Surgery for Colorectal Cancer	Laparoscopic surgery for colorectal cancer using STORZ laparoscope
DRUG	XELOX Chemotherapy	XELOX chemotherapy
DRUG	mFolfox6 chemotherapy	Conventional (mFolfox6) chemotherapy
OTHER	Fast Track Perioperative Treatment	Fast track treatment during perioperation period
OTHER	Conventional Perioperative Treatment	Conventional treatment during perioperation period
PROCEDURE	Open Surgery for Colorectal Cancer	Open surgery for colorectal cancer using conventional methods

Timeline

• Start date: 2010-03-01
• Primary completion: 2014-04-01
• Completion: 2014-12-01
• First posted: 2010-03-04
• Last updated: 2017-04-06

Locations

2 sites across 1 country: China