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

Zhejiang University

Status and phase: Completed; Phase 3

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

Treatments: Procedure: Open Surgery for Colorectal Cancer; Drug: XELOX Chemotherapy; Drug: mFolfox6 chemotherapy; Procedure: Laparoscopic Surgery for Colorectal Cancer; Other: Conventional Perioperative Treatment; Other: Fast Track Perioperative Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01080547

2009C13017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 374 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

374 participants in 4 patient groups

Conventional Treatment （Laparoscopic）

Active Comparator group

Description:

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

Treatment:

Other: Conventional Perioperative Treatment

Procedure: Laparoscopic Surgery for Colorectal Cancer

Drug: mFolfox6 chemotherapy

FTMD Treatment （Laparoscopic）

Active Comparator group

Description:

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

Treatment:

Other: Fast Track Perioperative Treatment

Procedure: Laparoscopic Surgery for Colorectal Cancer

Drug: XELOX Chemotherapy

Conventional Treatment（Open Surgery）

Active Comparator group

Description:

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

Treatment:

Other: Conventional Perioperative Treatment

Drug: mFolfox6 chemotherapy

Procedure: Open Surgery for Colorectal Cancer

FTMD Treatment（Open Surgery）

Active Comparator group

Description:

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

Treatment:

Other: Fast Track Perioperative Treatment

Drug: XELOX Chemotherapy

Procedure: Open Surgery for Colorectal Cancer