Study Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer

Phase 3

Completed

• Conditions: Adverse Drug Event; Length of Stay; Complications; Hospital Costs; Quality of Life
• Interventions: Drug: XELOX Chemotherapy; Procedure: Laparoscopic Surgery for Colorectal Cancer; Other: Fast Track Perioperative Treatment; Drug: mFolfox6 chemotherapy; Other: Conventional Perioperative Treatment; Procedure: Open Surgery for Colorectal Cancer

• Registration Number: NCT01080547
• Lead Sponsor: Zhejiang University

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-03
• Study First Posted: 2010-03-04
• Primary Completion: 2014-04
• Study Completion: 2014-12
• Status Verified: 2016-12
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 374

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Treatment （Laparoscopic）	Conventional Perioperative Treatment	Randomized group of patients receiving laparoscopic colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
Conventional Treatment（Open Surgery）	Conventional Perioperative Treatment	Randomized group of patients receiving open colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
Conventional Treatment（Open Surgery）	Open Surgery for Colorectal Cancer	Randomized group of patients receiving open colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
FTMD Treatment（Open Surgery）	Fast Track Perioperative Treatment	Randomized group of patients receiving open colectomy with Fast Track Multi-Displine（FTMD） treatment and XELOX chemotherapy.
FTMD Treatment （Laparoscopic）	Fast Track Perioperative Treatment	Randomized group of patients receiving laparoscopic colectomy with Fast Track Multi-Displine（FTMD）treatment and XELOX chemotherapy.
FTMD Treatment（Open Surgery）	XELOX Chemotherapy	Randomized group of patients receiving open colectomy with Fast Track Multi-Displine（FTMD） treatment and XELOX chemotherapy.
Conventional Treatment （Laparoscopic）	Laparoscopic Surgery for Colorectal Cancer	Randomized group of patients receiving laparoscopic colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
FTMD Treatment （Laparoscopic）	Laparoscopic Surgery for Colorectal Cancer	Randomized group of patients receiving laparoscopic colectomy with Fast Track Multi-Displine（FTMD）treatment and XELOX chemotherapy.
Conventional Treatment （Laparoscopic）	mFolfox6 chemotherapy	Randomized group of patients receiving laparoscopic colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
FTMD Treatment （Laparoscopic）	XELOX Chemotherapy	Randomized group of patients receiving laparoscopic colectomy with Fast Track Multi-Displine（FTMD）treatment and XELOX chemotherapy.
FTMD Treatment（Open Surgery）	Open Surgery for Colorectal Cancer	Randomized group of patients receiving open colectomy with Fast Track Multi-Displine（FTMD） treatment and XELOX chemotherapy.
Conventional Treatment（Open Surgery）	mFolfox6 chemotherapy	Randomized group of patients receiving open colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.

Primary Outcome Measures

Name	Time	Method
hospitalization day	6-month post surgery	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).

Secondary Outcome Measures

Name	Time	Method
chemotherapy related adverse event	6-month post surgery	Chemotherapy related adverse event, according to NCI CTCAE Version 3.0, include nausea, vomit, diarrhea and neutropenia etc.
surgical complications	3-month post surgery	Surgical complications include injury of ureter, intraoperative transfusion, infection of incision and anastomotic leakage etc.
hospitalization costs	6-month post surgery	The overall hospitalization costs from the first day in hospital to day that adjuvant chemotherapy finished.
quality of life	preoperation, 3-month post surgery and 6-month post surgery	Quality of life will be measured by EORTC QLQ-C30 and QLQ-CR38 questionaire.

Trial Locations

Locations (2)

Second Affiliated Hospital Zhejiang University College of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

People's Hospital of Shaoxing; 🇨🇳 Shaoxing, Zhejiang, China