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

Study Overview
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Brief Summary
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A new notionFast 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
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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 notionFast 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.

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

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

Intervention / Treatment
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* Procedure: Laparoscopic Surgery for Colorectal Cancer
* Drug: XELOX Chemotherapy
* Drug: mFolfox6 chemotherapy
* Other: Fast Track Perioperative Treatment
* Other: Conventional Perioperative Treatment
* Procedure: Open Surgery for Colorectal Cancer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with pathologically confirmed colorectal cancer Signed consent Exclusion Criteria: Tumor can be resected by endoscopic mucosal resection(EMR) History of malignancy Bowel obstruction or intestinal perforation Evidence of metastasis by physical examination, chest roentgenogram and computed tomography of liver and pelvis Acute diseases and acute attack of chronic diseases Psychiatric history Deformity of spine ASA score≥Ⅳ Mid-low rectal cancer Pregnant woman Needing to use Chinese traditional patent drug

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical complications | Surgical complications include injury of ureter, intraoperative transfusion, infection of incision and anastomotic leakage etc. | 3-month post surgery | 
| 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 | 
| 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 | 
| hospitalization costs | The overall hospitalization costs from the first day in hospital to day that adjuvant chemotherapy finished. | 6-month post surgery |