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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Zhejiang University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Zhejiang University
ClinicalTrials.gov Identifier:
NCT01080547
First received: March 1, 2010
Last updated: April 12, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention
Length of Stay
Complications
Adverse Drug Event
Quality of Life
Hospital Costs
Procedure: Laparoscopic Surgery for Colorectal Cancer
Drug: XELOX Chemotherapy
Drug: mFolfox6 chemotherapy
Other: Fast Track Perioperative Treatment
Other: Conventional Perioperative Treatment
Procedure: Open Surgery for Colorectal Cancer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Zhejiang University:

Primary Outcome Measures:
  • hospitalization day [ Time Frame: 6-month post surgery ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • surgical complications [ Time Frame: 3-month post surgery ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Quality of life will be measured by EORTC QLQ-C30 and QLQ-CR38 questionaire.

  • hospitalization costs [ Time Frame: 6-month post surgery ] [ Designated as safety issue: No ]
    The overall hospitalization costs from the first day in hospital to day that adjuvant chemotherapy finished.


Estimated Enrollment: 220
Study Start Date: March 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional Treatment (Laparoscopic)
Randomized group of patients receiving laparoscopic colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
Procedure: Laparoscopic Surgery for Colorectal Cancer
Laparoscopic surgery for colorectal cancer using STORZ laparoscope
Other Name: STORZ laparoscope
Drug: mFolfox6 chemotherapy
Conventional (mFolfox6) chemotherapy
Other Name: Oxaliplatin
Other: Conventional Perioperative Treatment
Conventional treatment during perioperation period
Other Name: Traditional Perioperative Treatment
Active Comparator: FTMD Treatment (Laparoscopic)
Randomized group of patients receiving laparoscopic colectomy with Fast Track Multi-Displine(FTMD)treatment and XELOX chemotherapy.
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
Other: Fast Track Perioperative Treatment
Fast track treatment during perioperation period
Other Name: Fast track surgery
Active Comparator: Conventional Treatment(Open Surgery)
Randomized group of patients receiving open colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.
Drug: mFolfox6 chemotherapy
Conventional (mFolfox6) chemotherapy
Other Name: Oxaliplatin
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
Active Comparator: FTMD Treatment(Open Surgery)
Randomized group of patients receiving open colectomy with Fast Track Multi-Displine(FTMD) treatment and XELOX chemotherapy.
Drug: XELOX Chemotherapy
XELOX chemotherapy
Other Names:
  • Capecitabine
  • Oxaliplatin
Other: Fast Track Perioperative Treatment
Fast track treatment during perioperation period
Other Name: Fast track surgery
Procedure: Open Surgery for Colorectal Cancer
Open surgery for colorectal cancer using conventional methods
Other Name: Traditional open surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01080547

Contacts
Contact: Ke-Feng Ding, PhD/MD 86-571-87784827 dingkefeng@zju.edu.cn

Locations
China, Zhejiang
Second Affiliated Hospital Zhejiang University College of Medicine Recruiting
Hangzhou, Zhejiang, China, 310999
Contact: Ke-Feng Ding, PhD/MD    86-571-87784827    dingkefeng@zju.edu.cn   
Principal Investigator: Ke-Feng Ding, PhD/MD         
People's Hospital of Shaoxing Recruiting
Shaoxing, Zhejiang, China, 312000
Contact: Xiao-Jiang Ying, MD    0575-88229151    lg_sx@sina.com   
Sub-Investigator: Xiao-Jiang Ying, MD         
Sponsors and Collaborators
Zhejiang University
Investigators
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.
  More Information

No publications provided by Zhejiang University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Ke-Feng Ding, Second Affiliated Hospital Zhejiang University College of Medicine
ClinicalTrials.gov Identifier: NCT01080547     History of Changes
Other Study ID Numbers: 2009C13017
Study First Received: March 1, 2010
Last Updated: April 12, 2010
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Colorectal Neoplasms
Drug-Related Side Effects and Adverse Reactions
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Chemically-Induced Disorders
Oxaliplatin
Capecitabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014