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Sponsored by: |
Medical Research Council |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003354 |
RATIONALE: Laparoscopic-assisted surgery is a less invasive type of surgery for colorectal cancer and may have fewer side effects and improve recovery. It is not yet known if undergoing conventional surgery is more effective than laparoscopic-assisted surgery for colorectal cancer.
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.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Procedure: conventional surgery Procedure: laparoscopic surgery |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Conventional Versus Laparoscopic-Assisted Surgery in Colorectal Cancer |
Estimated Enrollment: | 1200 |
Study Start Date: | July 1996 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United Kingdom, England | |
Airedale General Hospital | |
West Yorkshire, England, United Kingdom, BD20 6TD | |
Castle Hill Hospital | |
Cottingham, England, United Kingdom, HU16 5JQ | |
Imperial College School of Medicine at St. Mary's | |
London, England, United Kingdom, W2 1PG | |
Newcastle Upon Tyne Hospitals NHS Trust | |
Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN | |
Leeds General Infirmary at Leeds Teaching Hospital NHS Trust | |
Leeds, England, United Kingdom, LS1 3EX | |
Leeds Cancer Centre at St. James's University Hospital | |
Leeds, England, United Kingdom, LS9 7TF | |
Queen's Medical Centre | |
Nottingham, England, United Kingdom, NG7 2UH | |
Royal Liverpool and Broadgreen Hospitals | |
Liverpool, England, United Kingdom, L7 8XP | |
Salford Royal Hospitals NHS Trust | |
Salford, England, United Kingdom, M6 8HD | |
Saxon Clinic | |
Bucks, England, United Kingdom, MK6 5LR | |
United Kingdom, Scotland | |
Ninewells Hospital and Medical School | |
Dundee, Scotland, United Kingdom, DD1 9SY | |
Royal Infirmary of Edinburgh at Little France | |
Edinburgh, Scotland, United Kingdom, EH16 4SA | |
United Kingdom, Wales | |
University Hospital of Wales | |
Cardiff, Wales, United Kingdom, CF14 4XN |
Study Chair: | P.J. Guillou, MD | Leeds Cancer Centre at St. James's University Hospital |
Study ID Numbers: | CDR0000066336, MRC-CLASICC, NYCTRU-CLASICC, EU-98014, ISRCTN74883561 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003354 History of Changes |
Health Authority: | United States: Federal Government |
stage I colon cancer stage II colon cancer stage III colon cancer stage IV colon cancer stage 0 colon cancer |
stage 0 rectal cancer stage I rectal cancer stage II rectal cancer stage III rectal cancer stage IV rectal cancer |
Rectal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases |
Rectal Neoplasm Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |