Conventional Surgery Compared With Laparoscopic-Assisted Surgery in Treating Patients With Colorectal Cancer
NCT ID: NCT00003354
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1200 participants
INTERVENTIONAL
1996-07-31
2009-12-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying conventional surgery to see how well it works compared to laparoscopic-assisted surgery in treating patients with colorectal cancer.
Detailed Description
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* Determine whether longitudinal and circumferential resection margins and lymphatic clearances obtained during laparoscopic surgery are different from those obtained with conventional open surgery in patients with colorectal cancer.
* Compare the patterns of loco-regional or distant metastatic spread after these two surgical methods in these patients.
* Compare the morbidity and mortality rates in these patients after these two surgical methods, particularly in terms of the technical or thromboembolic complications that may develop as a consequence of prolonged pneumoperitoneum.
* Compare the disease-free or overall survival of these patients after these two operative procedures.
* Determine, in those patients in whom laparoscopic surgery fails, which investigatory modalities are appropriate for providing pre-operative indications that a patient is an inappropriate candidate for laparoscopic dissection.
* Compare the differences in quality of life between the two operative procedures, particularly in patients with advanced disease.
OUTLINE: This is a randomized, multicenter study.
Patients undergo laparoscopic surgery or conventional open surgery.
Patients are followed at 1 and 3 months following surgery, then every 3 months for the first year, every 4 months for the second year, and then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 1,200 patients will be accrued for this study within 5 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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conventional surgery
laparoscopic surgery
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed colorectal cancer
* Must be suitable for elective surgical resection by right hemicolectomy, left hemicolectomy, sigmoid colectomy, anterior resection or abdomino-perineal resection
* No adenocarcinoma of the transverse colon
* No synchronous multiple adenocarcinomas
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Pulmonary:
* No contraindication to pneumoperitoneum such as severe cardio-respiratory disease
Other:
* No acute intestinal obstruction
* No prior malignancy within the past 5 years, except basal cell carcinoma, carcinoma in situ of the cervix, or prostate cancer
* Not pregnant
* No gastrointestinal disease that requires surgical intervention, e.g., Crohn's disease, chronic ulcerative disease, familial polyposis
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
* Adjuvant chemotherapy allowed
Endocrine therapy:
* Not specified
Radiotherapy:
* Preoperative radiotherapy must be administered before randomization into this trial
* Adjuvant radiotherapy allowed
Surgery:
* See Disease Characteristics
18 Years
ALL
No
Sponsors
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Medical Research Council
OTHER_GOV
Principal Investigators
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P.J. Guillou, MD
Role: STUDY_CHAIR
Leeds Cancer Centre at St. James's University Hospital
Locations
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Saxon Clinic
Bucks, England, United Kingdom
Castle Hill Hospital
Cottingham, England, United Kingdom
Leeds General Infirmary at Leeds Teaching Hospital NHS Trust
Leeds, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Royal Liverpool and Broadgreen Hospitals
Liverpool, England, United Kingdom
Imperial College School of Medicine at St. Mary's
London, England, United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle upon Tyne, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Salford Royal Hospitals NHS Trust
Salford, England, United Kingdom
Airedale General Hospital
West Yorkshire, England, United Kingdom
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom
Royal Infirmary of Edinburgh at Little France
Edinburgh, Scotland, United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
Countries
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References
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Guillou PJ, Quirke P, Thorpe H, Walker J, Jayne DG, Smith AM, Heath RM, Brown JM; MRC CLASICC trial group. Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial. Lancet. 2005 May 14-20;365(9472):1718-26. doi: 10.1016/S0140-6736(05)66545-2.
Jayne DG, Brown JM, Thorpe H, Walker J, Quirke P, Guillou PJ. Bladder and sexual function following resection for rectal cancer in a randomized clinical trial of laparoscopic versus open technique. Br J Surg. 2005 Sep;92(9):1124-32. doi: 10.1002/bjs.4989.
Jayne DG, Guillou PJ, Thorpe H, Quirke P, Copeland J, Smith AM, Heath RM, Brown JM; UK MRC CLASICC Trial Group. Randomized trial of laparoscopic-assisted resection of colorectal carcinoma: 3-year results of the UK MRC CLASICC Trial Group. J Clin Oncol. 2007 Jul 20;25(21):3061-8. doi: 10.1200/JCO.2006.09.7758.
Jayne DG, Thorpe HC, Copeland J, Quirke P, Brown JM, Guillou PJ. Five-year follow-up of the Medical Research Council CLASICC trial of laparoscopically assisted versus open surgery for colorectal cancer. Br J Surg. 2010 Nov;97(11):1638-45. doi: 10.1002/bjs.7160.
Taylor GW, Jayne DG, Brown SR, Thorpe H, Brown JM, Dewberry SC, Parker MC, Guillou PJ. Adhesions and incisional hernias following laparoscopic versus open surgery for colorectal cancer in the CLASICC trial. Br J Surg. 2010 Jan;97(1):70-8. doi: 10.1002/bjs.6742.
Other Identifiers
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MRC-CLASICC
Identifier Type: -
Identifier Source: secondary_id
NYCTRU-CLASICC
Identifier Type: -
Identifier Source: secondary_id
EU-98014
Identifier Type: -
Identifier Source: secondary_id
ISRCTN74883561
Identifier Type: -
Identifier Source: secondary_id
CDR0000066336
Identifier Type: -
Identifier Source: org_study_id