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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01080547
Other study ID # 2009C13017
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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