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Trial record 1 of 1 for:    NCT01080547
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Study Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer
Study Start Date : March 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : December 2014
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01080547


Locations
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China, Zhejiang
Second Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, Zhejiang, China, 310999
People's Hospital of Shaoxing
Shaoxing, Zhejiang, China, 312000
Sponsors and Collaborators
Zhejiang University
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ding Ke-Feng, Professor of SAHZU, Zhejiang University
ClinicalTrials.gov Identifier: NCT01080547    
Other Study ID Numbers: 2009C13017
First Posted: March 4, 2010    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: December 2016
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Capecitabine
Oxaliplatin
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents