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| ID | Type | Description | Link |
|---|---|---|---|
| MRC-CLASICC | |||
| NYCTRU-CLASICC | |||
| EU-98014 | |||
| ISRCTN74883561 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional surgery | Procedure | |||
| laparoscopic surgery | Procedure |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| P.J. Guillou, MD | Leeds Cancer Centre at St. James's University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saxon Clinic | Bucks | England | MK6 5LR | United Kingdom | ||
| Castle Hill Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15894098 | Result | 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. | |
| 15997446 |
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| Cottingham |
| England |
| HU16 5JQ |
| United Kingdom |
| Leeds General Infirmary at Leeds Teaching Hospital NHS Trust | Leeds | England | LS1 3EX | United Kingdom |
| Leeds Cancer Centre at St. James's University Hospital | Leeds | England | LS9 7TF | United Kingdom |
| Royal Liverpool and Broadgreen Hospitals | Liverpool | England | L7 8XP | United Kingdom |
| Imperial College School of Medicine at St. Mary's | London | England | W2 1PG | United Kingdom |
| Newcastle Upon Tyne Hospitals NHS Trust | Newcastle upon Tyne | England | NE7 7DN | United Kingdom |
| Queen's Medical Centre | Nottingham | England | NG7 2UH | United Kingdom |
| Salford Royal Hospitals NHS Trust | Salford | England | M6 8HD | United Kingdom |
| Airedale General Hospital | West Yorkshire | England | BD20 6TD | United Kingdom |
| Ninewells Hospital and Medical School | Dundee | Scotland | DD1 9SY | United Kingdom |
| Royal Infirmary of Edinburgh at Little France | Edinburgh | Scotland | EH16 4SA | United Kingdom |
| University Hospital of Wales | Cardiff | Wales | CF14 4XN | United Kingdom |
| 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. |
| 17634484 | Result | 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. |
| 20629110 | Result | 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. |
| 20013936 | Result | 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. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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