Randomized Controlled Trial Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer
18 Years
N/A
Both
Length of Stay, Complications, Adverse Drug Event, Quality of Life, Hospital Costs
Trial Information
Randomized Controlled Trial Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
hospitalization day
Outcome Description:
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).
Outcome Time Frame:
6-month post surgery
Safety Issue:
No
Principal Investigator
Ke-Feng Ding, PhD/MD
Investigator Role:
Study Chair
Investigator Affiliation:
The Second Affiliated Hospital, and The Key Laboratory of Cancer Prevention and Intervention, China National Ministry of Education, Zhejiang University College of Medicine.
Authority:
China: Ministry of Health
Study ID:
2009C13017
NCT ID:
NCT01080547
Start Date:
March 2010
Completion Date:
January 2013
Related Keywords:
- Length of Stay
- Complications
- Adverse Drug Event
- Quality of Life
- Hospital Costs
- Colorectal Neoplasms
- Drug Toxicity
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