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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

374 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional Treatment （Laparoscopic）

Randomized group of patients receiving laparoscopic colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.

Group Type ACTIVE_COMPARATOR

Laparoscopic Surgery for Colorectal Cancer

Intervention Type PROCEDURE

Laparoscopic surgery for colorectal cancer using STORZ laparoscope

mFolfox6 chemotherapy

Intervention Type DRUG

Conventional (mFolfox6) chemotherapy

Conventional Perioperative Treatment

Intervention Type OTHER

Conventional treatment during perioperation period

FTMD Treatment （Laparoscopic）

Randomized group of patients receiving laparoscopic colectomy with Fast Track Multi-Displine（FTMD）treatment and XELOX chemotherapy.

Group Type ACTIVE_COMPARATOR

Laparoscopic Surgery for Colorectal Cancer

Intervention Type PROCEDURE

Laparoscopic surgery for colorectal cancer using STORZ laparoscope

XELOX Chemotherapy

Intervention Type DRUG

XELOX chemotherapy

Fast Track Perioperative Treatment

Intervention Type OTHER

Fast track treatment during perioperation period

Conventional Treatment（Open Surgery）

Randomized group of patients receiving open colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.

Group Type ACTIVE_COMPARATOR

mFolfox6 chemotherapy

Intervention Type DRUG

Conventional (mFolfox6) chemotherapy

Conventional Perioperative Treatment

Intervention Type OTHER

Conventional treatment during perioperation period

Open Surgery for Colorectal Cancer

Intervention Type PROCEDURE

Open surgery for colorectal cancer using conventional methods

FTMD Treatment（Open Surgery）

Randomized group of patients receiving open colectomy with Fast Track Multi-Displine（FTMD） treatment and XELOX chemotherapy.

Group Type ACTIVE_COMPARATOR

XELOX Chemotherapy

Intervention Type DRUG

XELOX chemotherapy

Fast Track Perioperative Treatment

Intervention Type OTHER

Fast track treatment during perioperation period

Open Surgery for Colorectal Cancer

Intervention Type PROCEDURE

Open surgery for colorectal cancer using conventional methods

Interventions

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Laparoscopic Surgery for Colorectal Cancer

Laparoscopic surgery for colorectal cancer using STORZ laparoscope

Intervention Type PROCEDURE

XELOX Chemotherapy

XELOX chemotherapy

Intervention Type DRUG

mFolfox6 chemotherapy

Conventional (mFolfox6) chemotherapy

Intervention Type DRUG

Fast Track Perioperative Treatment

Fast track treatment during perioperation period

Intervention Type OTHER

Conventional Perioperative Treatment

Conventional treatment during perioperation period

Intervention Type OTHER

Open Surgery for Colorectal Cancer

Open surgery for colorectal cancer using conventional methods

Intervention Type PROCEDURE

Other Intervention Names

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STORZ laparoscope Capecitabine Oxaliplatin Oxaliplatin Fast track surgery Traditional Perioperative Treatment Traditional open surgery

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Ding Ke-Feng

Professor of SAHZU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ke-Feng Ding, PhD/MD

Role: STUDY_CHAIR

The Second Affiliated Hospital, and The Key Laboratory of Cancer Prevention and Intervention, China National Ministry of Education, Zhejiang University College of Medicine.