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:
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
  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

  Hide Study Locations
Locations
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 April 16, 2014