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

Quality of Life Clinical Trial

Official title:

Randomized Controlled Trial Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080547
• Other study ID #: 2009C13017
• Status: Completed
• Phase: Phase 3
• First received: March 1, 2010
• Last updated: April 4, 2017
• Start date: March 2010
• Est. completion date: December 2014

Study information

• Verified date: December 2016
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: December 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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=?

9. Mid-low rectal cancer

10. Pregnant woman

11. Needing to use Chinese traditional patent drug

Related Conditions & MeSH terms

• Adverse Drug Event
• Colorectal Neoplasms
• Complications
• Drug-Related Side Effects and Adverse Reactions
• Hospital Costs
• Length of Stay
• Quality of Life

Intervention

Procedure:
• Laparoscopic Surgery for Colorectal Cancer
Laparoscopic surgery for colorectal cancer using STORZ laparoscope

Drug:
• XELOX Chemotherapy
XELOX chemotherapy
• mFolfox6 chemotherapy
Conventional (mFolfox6) chemotherapy

Other:
• Fast Track Perioperative Treatment
Fast track treatment during perioperation period
• Conventional Perioperative Treatment
Conventional treatment during perioperation period

Procedure:
• Open Surgery for Colorectal Cancer
Open surgery for colorectal cancer using conventional methods

Locations

Country	Name	City	State
China	Second Affiliated Hospital Zhejiang University College of Medicine	Hangzhou	Zhejiang
China	People's Hospital of Shaoxing	Shaoxing	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

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