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	Treatment or Intervention	Phase
Colon Cancer Rectal Cancer	Procedure: conventional surgery  Procedure: laparoscopic surgery  Procedure: surgery	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

United Kingdom, England
      Airedale General Hospital, West Yorkshire,  England,  BD20 6TD,  United Kingdom; Recruiting
      Castle Hill Hospital, Cottingham,  England,  HU16 5JQ,  United Kingdom; Recruiting
      Imperial College School of Medicine at St. Mary's, London,  England,  W2 1PG,  United Kingdom; Recruiting
      Leeds General Infirmary at Leeds Teaching Hospital NHS Trust, Leeds,  England,  LS1 3EX,  United Kingdom; Recruiting
      Newcastle Upon Tyne Hospitals NHS Trust, Newcastle upon Tyne,  England,  NE7 7DN,  United Kingdom; Recruiting
      Queen's Medical Centre, Nottingham,  England,  NG7 2UH,  United Kingdom; Recruiting
      Royal Liverpool and Broadgreen Hospitals, Liverpool,  England,  L7 8XP,  United Kingdom; Recruiting
      Salford Royal Hospitals NHS Trust, Salford,  England,  M6 8HD,  United Kingdom; Recruiting
      Saxon Clinic, Bucks,  England,  MK6 5LR,  United Kingdom; Recruiting
      St. James's University Hospital at Leeds Teaching Hospital NHS Trust, Leeds,  England,  LS9 7TF,  United Kingdom; Recruiting
United Kingdom, Scotland
      Ninewells Hospital and Medical School, Dundee,  Scotland,  DD1 9SY,  United Kingdom; Recruiting
      Royal Infirmary of Edinburgh at Little France, Edinburgh,  Scotland,  EH16 4SA,  United Kingdom; Recruiting
United Kingdom, Wales
      University Hospital of Wales, Cardiff,  Wales,  CF14 4XN,  United Kingdom; Recruiting

Study chairs or principal investigators

P.J. Guillou, MD,  Study Chair,  St. James's University Hospital at Leeds Teaching Hospital NHS Trust   

Study ID Numbers:  CDR0000066336; MRC-CLASICC; NYCTRU-CLASICC; EU-98014; ISRCTN74883561; NCT00003354
Record last reviewed:  February 2000
Last Updated:  April 4, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003354
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08