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NCT Number: NCT01080547

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Second Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, Zhejiang, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic Surgery for Colorectal Cancer

Procedure

Laparoscopic surgery for colorectal cancer using STORZ laparoscope

Other names: STORZ laparoscope

XELOX chemotherapy

Drug

XELOX chemotherapy

Other names: Capecitabine, Oxaliplatin

mFolfox6 chemotherapy

Drug

Conventional (mFolfox6) chemotherapy

Other names: Oxaliplatin

Fast Track Perioperative Treatment

Other

Fast track treatment during perioperation period

Other names: Fast track surgery

Conventional Perioperative Treatment

Other

Conventional treatment during perioperation period

Other names: Traditional Perioperative Treatment

Open Surgery for Colorectal Cancer

Procedure

Open surgery for colorectal cancer using conventional methods

Other names: Traditional open surgery

Primary outcomes

  1. 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

  1. surgical complications

    Time frame: 3-month post surgery

    Surgical complications include injury of ureter, intraoperative transfusion, infection of incision and anastomotic leakage etc.

  2. chemotherapy related adverse event

    Time frame: 6-month post surgery

    Chemotherapy related adverse event, according to NCI CTCAE Version 3.0, include nausea, vomit, diarrhea and neutropenia etc.

  3. quality of life

    Time frame: preoperation, 3-month post surgery and 6-month post surgery

    Quality of life will be measured by EORTC QLQ-C30 and QLQ-CR38 questionaire.

  4. hospitalization costs

    Time frame: 6-month post surgery

    The overall hospitalization costs from the first day in hospital to day that adjuvant chemotherapy finished.

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Mar 4, 2010
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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