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Home > "C" Clinical Trials Conditions > Conventional Surgery Compared With Laparoscopic-Assisted Surgery in Treating Patients With Colorectal Cancer  Conventional Surgery Compared With Laparoscopic-Assisted Surgery in Treating Patients With Colorectal Cancer
Conventional Surgery Compared With Laparoscopic-Assisted Surgery in Treating Patients With Colorectal Cancer
For Condition: Rectal Cancer,Colon Cancer
Status: Recruiting
Sponsor(s): Medical Research Council ,
Synopsis: 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: Randomizedphase III trial to compare the effectiveness of conventional surgery with that of laparoscopic-assisted surgery in treating patients who have colorectal cancer.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
P.J.Guillou, Study Chair, St. James's University Hospital
Queen's Medical Centre *Recruiting*
Nottingham, England, NG7 2UH
United Kingdom
Recruiting John Scholefield 44-115-924-9924
University of Wales College of Medicine *Recruiting*
Cardiff, Wales, CF14 4XN
United Kingdom
Recruiting D. Carey 44-29-2074-7747
Ninewells Hospital and Medical School *Recruiting*
Dundee, Scotland, DD1 9SY
United Kingdom
Recruiting S. Shimi 44-1382-660-111
Imperial College School of Medicine at St. Mary's *Recruiting*
London, England, W2 1PG
United Kingdom
Recruiting A. Darzi 44-171-723-1252
Airedale General Hospital *Recruiting*
West Yorkshire, England, BD20 6TD
United Kingdom
Recruiting R. Kapadia 01535292138
Royal Infirmary of Edinburgh at Little France *Recruiting*
Edinburgh, Scotland, EH16 4SA
United Kingdom
Recruiting D.C.C. Bartolo 131-536-1610
Royal Liverpool and Broadgreen Hospitals *Recruiting*
Liverpool, England, L7 8XP
United Kingdom
Recruiting M. Hershman 44-151-706-2000
St. James's University Hospital *Recruiting*
Leeds, England, LS9 7TF
United Kingdom
Recruiting Ian Lewis 44-113-206-4985
Newcastle Upon Tyne Hospitals NHS Trust *Recruiting*
Newcastle upon Tyne, England, NE7 7DN
United Kingdom
Recruiting J.S. Varma 0191-282-4384
Salford Royal Hospitals NHS Trust *Recruiting*
Salford, England, M6 8HD
United Kingdom
Recruiting N. Scott 44-161-789-7373
Leeds General Infirmary at Leeds Teaching Hospital NHS Trust *Recruiting*
Leeds, England, LS1 3EX
United Kingdom
Recruiting Peter Sagar 44-113-923-9748
Castle Hill Hospital *Recruiting*
Cottingham, England, HU16 5JQ
United Kingdom
Recruiting John Monson 44-1482-623-225
Walsall Manor Hospital *Recruiting*
Walsall, England, WS2 9PS
United Kingdom
Recruiting Jill Stewart 44-1922-721-172
Additional Information:
Study ID Numbers: CDR0000066336; MRC-CLASICC,NYCTRU-CLASICC,EU-98014,ISRCTN74883561
Study Start Date:
Record last reviewed: February 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003354
Other Colon Cancer Studies:
1. Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Colorectal Cancer
2. Octreotide in Preventing Diarrhea in Patients Receiving Chemotherapy for Colorectal Cancer
3. Eflornithine Plus Sulindac in Preventing Colorectal Cancer in Patients Who Have Had Surgery to Remove Benign Colorectal Polyps
4. Monoclonal Antibody Therapy and/or Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
5. Genetic Study of Patients and Families With a History of Colorectal Cancer
Related Studies:
Other Colon Cancer Clinical Trials
Other England Clinical Trials
Other Nottingham Clinical Trials
Conventional Surgery Compared With Laparoscopic-Assisted Surgery in Treating Patients With Colorectal Cancer
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