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

April 4, 2017 updated by: Ding Ke-Feng, Zhejiang University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

374

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310999
        • Second Affiliated Hospital Zhejiang University College of Medicine
      • Shaoxing, Zhejiang, China, 312000
        • People's Hospital of Shaoxing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Treatment （Laparoscopic）
Randomized group of patients receiving laparoscopic colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
Procedure: Laparoscopic Surgery for Colorectal Cancer
Laparoscopic surgery for colorectal cancer using STORZ laparoscope
Other Names:
  • STORZ laparoscope
Drug: mFolfox6 chemotherapy
Conventional (mFolfox6) chemotherapy
Other Names:
  • Oxaliplatin
Other: Conventional Perioperative Treatment
Conventional treatment during perioperation period
Other Names:
  • Traditional Perioperative Treatment
Active Comparator: FTMD Treatment （Laparoscopic）
Randomized group of patients receiving laparoscopic colectomy with Fast Track Multi-Displine（FTMD）treatment and XELOX chemotherapy.
Procedure: Laparoscopic Surgery for Colorectal Cancer
Laparoscopic surgery for colorectal cancer using STORZ laparoscope
Other Names:
  • STORZ laparoscope
Drug: XELOX Chemotherapy
XELOX chemotherapy
Other Names:
  • Capecitabine
  • Oxaliplatin
Other: Fast Track Perioperative Treatment
Fast track treatment during perioperation period
Other Names:
  • Fast track surgery
Active Comparator: Conventional Treatment（Open Surgery）
Randomized group of patients receiving open colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
Drug: mFolfox6 chemotherapy
Conventional (mFolfox6) chemotherapy
Other Names:
  • Oxaliplatin
Other: Conventional Perioperative Treatment
Conventional treatment during perioperation period
Other Names:
  • Traditional Perioperative Treatment
Procedure: Open Surgery for Colorectal Cancer
Open surgery for colorectal cancer using conventional methods
Other Names:
  • Traditional open surgery
Active Comparator: FTMD Treatment（Open Surgery）
Randomized group of patients receiving open colectomy with Fast Track Multi-Displine（FTMD） treatment and XELOX chemotherapy.
Drug: XELOX Chemotherapy
XELOX chemotherapy
Other Names:
  • Capecitabine
  • Oxaliplatin
Other: Fast Track Perioperative Treatment
Fast track treatment during perioperation period
Other Names:
  • Fast track surgery
Procedure: Open Surgery for Colorectal Cancer
Open surgery for colorectal cancer using conventional methods
Other Names:
  • Traditional open surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospitalization day
Time Frame: 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).
6-month post surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Investigators

  • 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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 1, 2010

First Submitted That Met QC Criteria

March 3, 2010

First Posted (Estimate)

March 4, 2010

Study Record Updates

Last Update Posted (Actual)

April 6, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009C13017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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