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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003354
First received: November 1, 1999
Last updated: December 3, 2013
Last verified: January 2001
  Purpose

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 Intervention Phase
Colorectal Cancer
Procedure: conventional surgery
Procedure: laparoscopic surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Conventional Versus Laparoscopic-Assisted Surgery in Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 1200
Study Start Date: July 1996
Study Completion Date: December 2009
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003354

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00003354     History of Changes
Other Study ID Numbers: CDR0000066336, MRC-CLASICC, NYCTRU-CLASICC, EU-98014, ISRCTN74883561
Study First Received: November 1, 1999
Last Updated: December 3, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on November 19, 2014