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

This study is ongoing, but not recruiting participants.

Sponsored by: Medical Research Council
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003354
  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 III

MedlinePlus related topics:   Cancer    Colorectal Cancer   

U.S. FDA Resources

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

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

Estimated Enrollment:   1200
Study Start Date:   July 1996

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

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

Locations
United Kingdom, England
Airedale General Hospital    
      West Yorkshire, England, United Kingdom, BD20 6TD
Castle Hill Hospital    
      Cottingham, England, United Kingdom, HU16 5JQ
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
Leeds General Infirmary at Leeds Teaching Hospital NHS Trust    
      Leeds, England, United Kingdom, LS1 3EX
Leeds Cancer Centre at St. James's University Hospital    
      Leeds, England, United Kingdom, LS9 7TF
Queen's Medical Centre    
      Nottingham, England, United Kingdom, NG7 2UH
Royal Liverpool and Broadgreen Hospitals    
      Liverpool, England, United Kingdom, L7 8XP
Salford Royal Hospitals NHS Trust    
      Salford, England, United Kingdom, M6 8HD
Saxon Clinic    
      Bucks, England, United Kingdom, MK6 5LR
United Kingdom, Scotland
Ninewells Hospital and Medical School    
      Dundee, Scotland, United Kingdom, DD1 9SY
Royal Infirmary of Edinburgh at Little France    
      Edinburgh, Scotland, United Kingdom, EH16 4SA
United Kingdom, Wales
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

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000066336, MRC-CLASICC, NYCTRU-CLASICC, EU-98014, ISRCTN74883561
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003354
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

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal cancer
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on September 05, 2008




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