Randomized Controlled Trial Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer
Overview
- Phase
- Phase 3
- Intervention
- Laparoscopic Surgery for Colorectal Cancer
- Conditions
- Length of Stay
- Sponsor
- Zhejiang University
- Enrollment
- 374
- Locations
- 2
- Primary Endpoint
- hospitalization day
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
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.
Investigators
Ding Ke-Feng
Professor of SAHZU
Zhejiang University
Eligibility Criteria
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
Arms & Interventions
Conventional Treatment （Laparoscopic）
Randomized group of patients receiving laparoscopic colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
Intervention: Laparoscopic Surgery for Colorectal Cancer
Conventional Treatment （Laparoscopic）
Randomized group of patients receiving laparoscopic colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
Intervention: mFolfox6 chemotherapy
Conventional Treatment （Laparoscopic）
Randomized group of patients receiving laparoscopic colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
Intervention: Conventional Perioperative Treatment
FTMD Treatment （Laparoscopic）
Randomized group of patients receiving laparoscopic colectomy with Fast Track Multi-Displine（FTMD）treatment and XELOX chemotherapy.
Intervention: Laparoscopic Surgery for Colorectal Cancer
FTMD Treatment （Laparoscopic）
Randomized group of patients receiving laparoscopic colectomy with Fast Track Multi-Displine（FTMD）treatment and XELOX chemotherapy.
Intervention: XELOX Chemotherapy
FTMD Treatment （Laparoscopic）
Randomized group of patients receiving laparoscopic colectomy with Fast Track Multi-Displine（FTMD）treatment and XELOX chemotherapy.
Intervention: Fast Track Perioperative Treatment
Conventional Treatment（Open Surgery）
Randomized group of patients receiving open colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
Intervention: mFolfox6 chemotherapy
Conventional Treatment（Open Surgery）
Randomized group of patients receiving open colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
Intervention: Conventional Perioperative Treatment
Conventional Treatment（Open Surgery）
Randomized group of patients receiving open colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
Intervention: Open Surgery for Colorectal Cancer
FTMD Treatment（Open Surgery）
Randomized group of patients receiving open colectomy with Fast Track Multi-Displine（FTMD） treatment and XELOX chemotherapy.
Intervention: XELOX Chemotherapy
FTMD Treatment（Open Surgery）
Randomized group of patients receiving open colectomy with Fast Track Multi-Displine（FTMD） treatment and XELOX chemotherapy.
Intervention: Fast Track Perioperative Treatment
FTMD Treatment（Open Surgery）
Randomized group of patients receiving open colectomy with Fast Track Multi-Displine（FTMD） treatment and XELOX chemotherapy.
Intervention: Open Surgery for Colorectal Cancer
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- chemotherapy related adverse event(6-month post surgery)
- surgical complications(3-month post surgery)
- hospitalization costs(6-month post surgery)
- quality of life(preoperation, 3-month post surgery and 6-month post surgery)