Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Conventional Surgery Compared With Laparoscopic-Assisted Surgery in Treating Patients With Colorectal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	Other	MRC-CLASICC NYCTRU-CLASICC, EU-98014, ISRCTN74883561, NCT00003354

Objectives

1. 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.
2. Compare the patterns of loco-regional or distant metastatic spread after these two surgical methods in these patients.
3. 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.
4. Compare the disease-free or overall survival of these patients after these two operative procedures.
5. 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.
6. Compare the differences in quality of life between the two operative procedures, particularly in patients with advanced disease.

Entry Criteria

Disease Characteristics:

• 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

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

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

Expected Enrollment

Approximately 1,200 patients will be accrued for this study within 5 years.

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.

Guillou PJ, Quirke P, Thorpe H, et al.: Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial. Lancet 365 (9472): 1718-26, 2005 May 14-20.[PUBMED Abstract]

Jayne DG, Brown JM, Thorpe H, et al.: Bladder and sexual function following resection for rectal cancer in a randomized clinical trial of laparoscopic versus open technique. Br J Surg 92 (9): 1124-32, 2005.[PUBMED Abstract]

Jayne DG, Guillou PJ, Thorpe H, et al.: Randomized trial of laparoscopic-assisted resection of colorectal carcinoma: 3-year results of the UK MRC CLASICC Trial Group. J Clin Oncol 25 (21): 3061-8, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

P.J. Guillou, MD, Protocol chair		Ph: 44-113-206-6400

Registry Information
Official Title		Conventional Versus Laparoscopic-Assisted Surgery in Colorectal Cancer
Trial Start Date		1996-07-01
Registered in ClinicalTrials.gov		NCT00003354
Date Submitted to PDQ		1998-05-29
Information Last Verified		2001-01-08

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