Clinical trial NCT00003354: Conventional Surgery Compared With Laparoscopic-Assisted Surgery in Treating Patients With Colorectal Cancer
Official title: Conventional Versus Laparoscopic-Assisted Surgery in Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: OBJECTIVES:

* 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.

Eligibility 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

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bucks
country: United Kingdom
facility: Saxon Clinic
state: England
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
state: England
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary at Leeds Teaching Hospital NHS Trust
state: England
city: Leeds
country: United Kingdom
facility: Leeds Cancer Centre at St. James's University Hospital
state: England
city: Liverpool
country: United Kingdom
facility: Royal Liverpool and Broadgreen Hospitals
state: England
city: London
country: United Kingdom
facility: Imperial College School of Medicine at St. Mary's
state: England
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Newcastle Upon Tyne Hospitals NHS Trust
state: England
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
state: England
city: Salford
country: United Kingdom
facility: Salford Royal Hospitals NHS Trust
state: England
city: West Yorkshire
country: United Kingdom
facility: Airedale General Hospital
state: England
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
state: Scotland
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh at Little France
state: Scotland
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
state: Wales
Study officials:
affiliation: Leeds Cancer Centre at St. James's University Hospital
name: P.J. Guillou, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.