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A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00147134
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : September 22, 2016
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Haruhiko Fukuda, Japan Clinical Oncology Group

Study Description
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Brief Summary:
The purpose of this study is to evaluate oncological outcome of patients for T3 and T4 colorectal cancer undergoing laparoscopic versus open surgery.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: open colectomy Procedure: laparoscopic colectomy Phase 3

Detailed Description:
The benefits of laparoscopic surgery (LAP) in comparison to open surgery (OPEN) have been suggested with respect to decreased morbidity, decreased pain, faster recovery, and shorter hospital stay.1-4 However, the long-term survival of LAP for colorectal cancer is still unclear, especially for advanced colorectal cancer requiring extended lymphadenectomy. Thus, the investigators designed a study which investigates whether LAP is suitable for advanced colorectal cancer with respect to survival and post-operative morbidity.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer（JCOG 0404,CRC Surg-LAP/OPEN)
Study Start Date : November 2004
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Procedure/Surgery: open colectomy
 Procedure: open colectomy
Procedure/Surgery: open colectomy
Experimental: 2
Procedure/Surgery: laparoscopic colectomy
 Procedure: laparoscopic colectomy
Procedure/Surgery: laparoscopic colectomy


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: During the study conduct ]

Secondary Outcome Measures :
  1. Relapse-free survival [ Time Frame: During the study conduct ]
  2. Short-term clinical outcomes [ Time Frame: time to 1st discharge after operation ]
  3. Adverse events [ Time Frame: During the study conduct ]
  4. The proportion of conversion from LAP to OPEN [ Time Frame: operation day ]
  5. The proportion of completion of LAP [ Time Frame: operation day ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically proven colorectal carcinoma
  2. Tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon
  3. T3 or deeper lesion without involvement of other organs
  4. Without multiple lesion other than carcinoma in situ
  5. Cancer classified as N0-2 and M0, according to the TNM classification system
  6. Tumor size < 8 cm
  7. No bowel obstruction
  8. Age 20 < and > 75 years
  9. Sufficient organ function
  10. No history of gastrointestinal surgery
  11. No history of chemotherapy or radiotherapy
  12. Provided written informed consent

Exclusion Criteria:

  1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
  2. Severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease
  3. Pregnant or lactating women
  4. Severe mental disease
  5. Continuous systemic steroid therapy
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): NCT00147134


Locations
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Sponsors and Collaborators
Haruhiko Fukuda
Ministry of Health, Labour and Welfare, Japan
Investigators
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Study Chair: Seigo Kitano, MD, PhD,FACS Oita University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00147134    
Other Study ID Numbers: JCOG0404
C000000105
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016
Keywords provided by Haruhiko Fukuda, Japan Clinical Oncology Group:
colorectal cancer
laparoscopic surgery
randomized controlled trial
oncological outcome
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases