Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Stage IIA, Stage IIIA, or Stage IIIB Rectal Cancer
This study is currently recruiting participants.
Verified February 2013 by National Cancer Institute (NCI)
Sponsor:
American College of Surgeons
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00726622
First received: July 31, 2008
Last updated: February 7, 2013
Last verified: February 2013
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Purpose
RATIONALE: Laparoscopic-assisted resection is a less invasive type of surgery for rectal cancer and may have fewer side effects and improve recovery. It is not yet known whether laparoscopic-assisted resection is more effective than open resection in treating patients with rectal cancer.
PURPOSE: This randomized phase III trial is studying laparoscopic-assisted resection to see how well it works compared with open resection in treating patients with stage IIA, stage IIIA, or stage IIIB rectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Procedure: therapeutic conventional surgery Procedure: therapeutic laparoscopic surgery |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Phase III Prospective Randomized Trial Comparing Laparoscopic-assisted Resection Versus Open Resection for Rectal Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Circumferential margin > 1 mm [ Designated as safety issue: No ]
- Negative distal resected margin [ Designated as safety issue: No ]
- Completeness of total mesorectal excision (complete or nearly complete) [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Patient-related benefit [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
- Local pelvic recurrence rates [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Sexual function and bowel function [ Designated as safety issue: No ]
| Estimated Enrollment: | 650 |
| Study Start Date: | August 2008 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients undergo open laparotomy and rectal resection.
|
Procedure: therapeutic conventional surgery
Patients undergo open laparotomy and rectal resection.
|
|
Experimental: Arm II
Patients undergo laparoscopic-assisted rectal resection.
|
Procedure: therapeutic laparoscopic surgery
Patients undergo laparoscopic-assisted rectal resection.
|
Detailed Description:
OBJECTIVES:
Primary
- To test the hypothesis that laparoscopic-assisted resection is not inferior to open resection, based on a composite primary endpoint of oncologic factors that are indicative of a safe and feasible surgical resection, in patients with stage IIA, IIIA, or IIIB rectal cancer.
Secondary
- To compare the patient-related benefit of laparoscopic-assisted resection vs open resection, in terms of blood loss, length of stay, and utilization of pain medication.
- To compare the disease-free survival and local pelvic recurrence at 2 years.
- To compare the quality of life, sexual function, and bowel and stoma function.
OUTLINE: This is a multicenter study. Patients are stratified according to site of primary tumor (high vs middle vs low rectum), registering surgeon, and planned operative procedure (low anterior resection vs abdominal perineal resection). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo open laparotomy and rectal resection.
- Arm II: Patients undergo laparoscopic-assisted rectal resection. Quality of life is assessed periodically using EORTC Quality of Life Questionnaires (EORTC QLQ-C30 and -CR38), the Linear Analog Self-Assessment (LASA), the Stoma Quality of Life Scale (SQOLS), and the Mayo Bowel Function Questionnaire (MBFQ).
After completion of study treatment, patients are followed periodically for up to 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 adenocarcinoma of the rectum (≤ 12 cm from the anal verge)
T3, N0, M0 or T1-3, N1-2, M0 disease by pre-neoadjuvant therapy CT scans and pelvic MRI or transrectal ultrasound
- No T4 disease
Must have completed neoadjuvant fluorouracil-based chemotherapy and/or radiotherapy within the past 4 weeks
- Capecitabine may have been substituted for fluorouracil
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Body mass index ≤ 34
- Negative pregnancy test
- No evidence of conditions (e.g., multiple prior major laparotomies or severe adhesions) that would preclude use of a laparoscopic approach
- No systemic disease (e.g., cardiovascular, renal, or hepatic) that would preclude surgery
- No other severe incapacitating disease (i.e., ASA IV [severe systemic disease that is a constant threat to life] or ASA V [moribund and is not expected to survive without the operation])
- No other invasive pelvic malignancy (cervical, uterine, or rectal) within the past 5 years
- No history of psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00726622
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| United States, Arizona | |
| Mayo Clinic Scottsdale | Recruiting |
| Scottsdale, Arizona, United States, 85259-5499 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, California | |
| Cancer Care Center at John Muir Health - Concord Campus | Recruiting |
| Concord, California, United States, 94524-4110 | |
| Contact: Clinical Trials Office - Cancer Care Center at John Muir Healt 925-674-2580 | |
| Kaiser Permanente Medical Center - Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Maher A. Abbas 323-667-4011 | |
| California Pacific Medical Center - California Campus | Recruiting |
| San Francisco, California, United States, 94118 | |
| Contact: David H. Irwin, MD 510-204-1591 | |
| John Muir/Mt. Diablo Comprehensive Cancer Center | Recruiting |
| Walnut Creek, California, United States, 94598 | |
| Contact: Clinical Trials Office - John Muir/Mt. Diablo Comprehensive Ca 925-941-4246 | |
| United States, Florida | |
| Cleveland Clinic Florida - Weston | Recruiting |
| Weston, Florida, United States, 33331 | |
| Contact: Clinical Trials Office - Cleveland Clinic Florida - Weston 954-659-5705 | |
| United States, Georgia | |
| John B. Amos Cancer Center | Recruiting |
| Columbus, Georgia, United States, 31904 | |
| Contact: Clinical Trials Office - John B. Amos Cancer Center 706-660-6404 | |
| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611-3013 | |
| Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu | |
| Evanston Hospital | Recruiting |
| Evanston, Illinois, United States, 60201-1781 | |
| Contact: Clinical Trials Office - Evanston Hospital 847-570-1381 | |
| United States, Indiana | |
| Clarian North Medical Center | Recruiting |
| Carmel, Indiana, United States, 46032 | |
| Contact: Virgilio George 317-688-2000 | |
| Indiana University Melvin and Bren Simon Cancer Center | Recruiting |
| Indianapolis, Indiana, United States, 46202-5289 | |
| Contact: Clinical Trials Office - Indiana University Cancer Center 317-274-2552 | |
| Veterans Affairs Medical Center - Indianapolis | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Virgilio George 317-554-0000 | |
| William N. Wishard Memorial Hospital | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Virgilio George 317-639-6671 | |
| Kendrick Regional Center for Colon and Rectal Care - Mooresville | Recruiting |
| Mooresville, Indiana, United States, 46158 | |
| Contact: Dipen C. Maun 317-834-2020 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242-1002 | |
| Contact: Cancer Information Service 800-237-1225 | |
| United States, Massachusetts | |
| Lahey Clinic Medical Center - Burlington | Recruiting |
| Burlington, Massachusetts, United States, 01805 | |
| Contact: Clinical Trials Office - Lahey Clinic Medical Center - Burling 781-744-8027 | |
| United States, Michigan | |
| Blodgett Hospital at Spectrum Health | Recruiting |
| Grand Rapids, Michigan, United States, 49506 | |
| Contact: Rebecca E. Hoedema 616-774-7444 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, Missouri | |
| Boone Hospital Center | Recruiting |
| Columbia, Missouri, United States, 65201 | |
| Contact: Walter R. Peters, Jr. 573-815-8000 | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: James W. Fleshman, Jr. 314-747-7222 | |
| United States, New Jersey | |
| Overlook Hospital | Recruiting |
| Summit, New Jersey, United States, 07901 | |
| Contact: Bertram T. Chinn 908-522-2000 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Martin R. Weiser 212-639-8895 | |
| Stony Brook University Cancer Center | Recruiting |
| Stony Brook, New York, United States, 11794-9446 | |
| Contact: Clinical Trials Office - Stony Brook University Cancer Center 800-862-2215 | |
| SUNY Upstate Medical University Hospital | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476 | |
| United States, North Carolina | |
| Duke Cancer Institute | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Clinical Trials Office - Duke Cancer Institute 888-275-3853 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100 | |
| United States, Oklahoma | |
| INTEGRIS Cancer Institute of Oklahoma - Proton Campus | Recruiting |
| Oklahoma City, Oklahoma, United States, 73142 | |
| Contact: Chris M. Davis, MD 405-949-3870 | |
| United States, Oregon | |
| Providence Cancer Center at Providence Portland Medical Center | Recruiting |
| Portland, Oregon, United States, 97213-2967 | |
| Contact: Clinical Trials Office - Providence Cancer Center at Providenc 503-215-6412 | |
| United States, Pennsylvania | |
| Forbes Regional Hospital | Recruiting |
| Monroeville, Pennsylvania, United States, 15146 | |
| Contact: James T. McCormick 412-858-2000 | |
| Allegheny Cancer Center at Allegheny General Hospital | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Contact: James T. McCormick 412-359-3336 | |
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15224-1791 | |
| Contact: James T. McCormick 412-578-5000 | |
| Lankenau Cancer Center at Lankenau Hospital | Recruiting |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Contact: Ned Z. Carp, MD 610-642-1908 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
| United States, Wisconsin | |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
| Madison, Wisconsin, United States, 53792-6164 | |
| Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo 608-262-5223 | |
| Medical College of Wisconsin Cancer Center | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C 414-805-4380 | |
| Canada, British Columbia | |
| St. Paul's Hospital at Providence Health Care - Vancouver | Recruiting |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Contact: P. T. Phang 604-806-9090 | |
| Canada, Ontario | |
| St. Joseph's Hospital - Charlton Campus | Recruiting |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| Contact: Mehran Anvari 905-522-4941 | |
Sponsors and Collaborators
American College of Surgeons
Investigators
| Study Chair: | James W. Fleshman, MD | Washington University Siteman Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | David M. Ota, American College of Surgeons Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00726622 History of Changes |
| Other Study ID Numbers: | CDR0000601816, ACOSOG-Z6051 |
| Study First Received: | July 31, 2008 |
| Last Updated: | February 7, 2013 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage IIA rectal cancer stage IIIA rectal cancer stage IIIB rectal cancer adenocarcinoma of the rectum |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Colonic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013