Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01080547
Recruitment Status : Completed
First Posted : March 4, 2010
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Ding Ke-Feng, Zhejiang University

Tracking Information
First Submitted Date  ICMJE March 1, 2010
First Posted Date  ICMJE March 4, 2010
Last Update Posted Date April 6, 2017
Study Start Date  ICMJE March 2010
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2010)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2010)
  • surgical complications [ Time Frame: 3-month post surgery ]
    Surgical complications include injury of ureter, intraoperative transfusion, infection of incision and anastomotic leakage etc.
  • 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.
  • 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.
  • hospitalization costs [ Time Frame: 6-month post surgery ]
    The overall hospitalization costs from the first day in hospital to day that adjuvant chemotherapy finished.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer
Official Title  ICMJE Randomized Controlled Trial Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Length of Stay
  • Complications
  • Adverse Drug Event
  • Quality of Life
  • Hospital Costs
Intervention  ICMJE
  • Procedure: Laparoscopic Surgery for Colorectal Cancer
    Laparoscopic surgery for colorectal cancer using STORZ laparoscope
    Other Name: STORZ laparoscope
  • Drug: XELOX Chemotherapy
    XELOX chemotherapy
    Other Names:
    • Capecitabine
    • Oxaliplatin
  • Drug: mFolfox6 chemotherapy
    Conventional (mFolfox6) chemotherapy
    Other Name: Oxaliplatin
  • Other: Fast Track Perioperative Treatment
    Fast track treatment during perioperation period
    Other Name: Fast track surgery
  • Other: Conventional Perioperative Treatment
    Conventional treatment during perioperation period
    Other Name: Traditional Perioperative Treatment
  • Procedure: Open Surgery for Colorectal Cancer
    Open surgery for colorectal cancer using conventional methods
    Other Name: Traditional open surgery
Study Arms  ICMJE
  • Active Comparator: Conventional Treatment (Laparoscopic)
    Randomized group of patients receiving laparoscopic colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
    Interventions:
    • Procedure: Laparoscopic Surgery for Colorectal Cancer
    • Drug: mFolfox6 chemotherapy
    • Other: Conventional Perioperative Treatment
  • Active Comparator: FTMD Treatment (Laparoscopic)
    Randomized group of patients receiving laparoscopic colectomy with Fast Track Multi-Displine(FTMD)treatment and XELOX chemotherapy.
    Interventions:
    • Procedure: Laparoscopic Surgery for Colorectal Cancer
    • Drug: XELOX Chemotherapy
    • Other: Fast Track Perioperative Treatment
  • Active Comparator: Conventional Treatment(Open Surgery)
    Randomized group of patients receiving open colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
    Interventions:
    • Drug: mFolfox6 chemotherapy
    • Other: Conventional Perioperative Treatment
    • Procedure: Open Surgery for Colorectal Cancer
  • Active Comparator: FTMD Treatment(Open Surgery)
    Randomized group of patients receiving open colectomy with Fast Track Multi-Displine(FTMD) treatment and XELOX chemotherapy.
    Interventions:
    • Drug: XELOX Chemotherapy
    • Other: Fast Track Perioperative Treatment
    • Procedure: Open Surgery for Colorectal Cancer
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2016)
374
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2010)
220
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01080547
Other Study ID Numbers  ICMJE 2009C13017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ding Ke-Feng, Zhejiang University
Study Sponsor  ICMJE Zhejiang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ke-Feng Ding, PhD/MD The Second Affiliated Hospital, and The Key Laboratory of Cancer Prevention and Intervention, China National Ministry of Education, Zhejiang University College of Medicine.
PRS Account Zhejiang University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP