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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) Southwest Oncology Group Eastern Cooperative Oncology Group Radiation Therapy Oncology Group Cancer and Leukemia Group B NCIC Clinical Trials Group National Surgical Adjuvant Breast and Bowel Project (NSABP) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002575 |
RATIONALE: Less invasive types of surgery may help reduce the number of side effects and improve recovery. It is not yet known which type of surgery is more effective for colon cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of laparoscopic-assisted colectomy with open colectomy in treating patients who have colon cancer.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Procedure: conventional surgery Procedure: laparoscopic surgery |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A PHASE III PROSPECTIVE RANDOMIZED TRIAL COMPARING LAPAROSCOPIC-ASSISTED COLECTOMY VERSUS OPEN COLECTOMY FOR COLON CANCER |
Estimated Enrollment: | 810 |
Study Start Date: | August 1994 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, primary surgeon, site of primary tumor (right vs left vs sigmoid), and American Society of Anesthesiologists disease classification (I and II vs III). Patients are randomized to one of two treatment arms.
The extent of colon resection is identical for both arms.
Otherwise, a right or left colectomy or sigmoid resection is performed using laparoscopic-assisted techniques. Patients may be entered on adjuvant chemotherapy trials after surgery provided the subsequent trial does not include radiotherapy and allows entry of patients from both arms.
Quality of life is assessed at baseline and on days 2 and 14 after surgery, at 2 months, and then at 18 months.
(closed as of 4/30/99)
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 810 patients will be accrued for this study within 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Clinical diagnosis of primary adenocarcinoma
Involving a single colon segment:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Heidi Nelson, MD | Mayo Clinic |
Study Chair: | Robert W. Beart, MD | USC/Norris Comprehensive Cancer Center |
Study Chair: | Mark S. Talamonti, MD | Robert H. Lurie Cancer Center |
Study Chair: | John M. Skibber, MD | M.D. Anderson Cancer Center |
Study Chair: | Jane C. Weeks, MD | Dana-Farber Cancer Institute |
Study Chair: | Hartley S. Stern, MD | Ottawa Hospital Regional Cancer Centre - General Campus |
Study Chair: | Thomas B. Julian, MD | Allegheny Cancer Center at Allegheny General Hospital |
Study ID Numbers: | CDR0000063648, NCCTG-934653, CAN-NCIC-CO12, CLB-9396, E-7293, NSABP-CI64, RTOG-9415, SWOG-9411, INT-0146 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002575 History of Changes |
Health Authority: | United States: Federal Government |
stage I colon cancer stage II colon cancer stage III colon cancer adenocarcinoma of the colon |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Gastrointestinal Neoplasms Intestinal Diseases |
Adenocarcinoma Rectal Diseases Colonic Neoplasms Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Colonic Neoplasms Intestinal Neoplasms Colorectal Neoplasms |