Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Rectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00726622
First received: July 31, 2008
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

This study is being done to compare two types of surgery currently used for rectal cancer. The two types of surgery are laparoscopic-assisted rectal resection and open laparotomy rectal resection. Although laparoscopic-assisted rectal resection is being used for rectal cancer in some medical centers, the effectiveness of this type of surgery compared to open surgery is unknown. The study will compare the safety and effectiveness of the surgeries, recovery from surgery in the hospital, overall recovery from surgery and cancer outcome.


Condition Intervention Phase
Colorectal Cancer
Procedure: Open laparotomy and rectal resection
Procedure: Laparoscopic-assisted rectal resection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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 Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Circumferential margin > 1 mm [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
  • Negative distal resected margin [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
  • Completeness of total mesorectal excision (complete or nearly complete) [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient-related benefit (length of stay, operative times and use of pain medication) [ Time Frame: Up to 5 years post surgery ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: Up to 2 years post surgery ] [ Designated as safety issue: No ]
  • Local pelvic recurrence rates [ Time Frame: Up to 2 years post surgery ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 5 years post surgery ] [ Designated as safety issue: No ]
  • Quality of life and sexual function [ Time Frame: Up to 5 years post surgery ] [ Designated as safety issue: No ]
  • Bowel function [ Time Frame: Up to 5 years post surgery ] [ Designated as safety issue: No ]
  • Bowel and stoma function [ Time Frame: Up to 5 years post surgery ] [ Designated as safety issue: No ]

Enrollment: 486
Study Start Date: August 2008
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1: Open laparotomy and rectal resection
Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
Procedure: Open laparotomy and rectal resection
Patients undergo open laparotomy and rectal resection.
Experimental: Arm 2: Laparoscopic-assisted rectal resection
Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
Procedure: Laparoscopic-assisted rectal resection
Patients undergo laparoscopic-assisted rectal resection.

Detailed Description:

This is a multicenter study. Patients eligible for this trial will have completed 5FU based neoadjuvant chemotherapy/radiation therapy per the institution's standard of care or IRB approved clinical trial. Patients may be registered/randomized anytime after completion of neoadjuvant therapy, but surgery must occur within 4-12 weeks (28-84 days) after completion of neoadjuvant therapy. Patients are stratified according to the site of the primary tumor (high, middle or low rectum), registering surgeon, and planned operative procedure (low anterior resection or abdominal perineal resection). Patients are randomized to 1 of 2 treatment arms. Please see the arms section for more details. The primary and secondary objectives are listed below.

Primary Objective:

To test the hypothesis that laparoscopic-assisted resection for rectal cancer is not inferior to open rectal resection, based on a composite primary endpoint of oncologic factors which are indicative of a safe and feasible operation.

Secondary Objectives:

  1. To assess patient-related benefit of laparoscopic-assisted resection for rectal cancer vs.

    open rectal resection (blood loss, length of stay, pain medicine utilization)

  2. To assess disease free survival and local pelvic recurrence at two years.
  3. To assess quality of life, sexual function, bowel and stoma function at scheduled time points throughout the trial.

Patients will be evaluated after surgery to determine the need for subsequent care based on the final pathology. Patients should not start treatment on any other investigative trial involving intervention or invasive diagnostic procedures ≤ 30 days following surgery to enable a complete evaluation of post-operative adverse events and complications occurring within 30 days of surgery. Patients are followed periodically for up to 5 years post surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria:

  1. Histologic diagnosis of adenocarcinoma of the rectum (≤ 12 cm from the anal verge)
  2. T3, N0, M0, T1-3, N1-2, M0 disease as determined by pre-neoadjuvant therapy CT scans and pelvic MRI or transrectal ultrasound. Patients with T4 disease are not eligible.
  3. Completion of pre-operative 5FU based chemotherapy and/or radiation therapy. Capecitabine may be substituted for 5FU.
  4. Age ≥ 18 years
  5. ECOG (Zubrod) Performance Status ≤ 2
  6. Body Mass Index (BMI) ≤ 34
  7. No evidence of conditions that would preclude use of a laparoscopic approach (eg, multiple previous major laparotomies, severe adhesions)
  8. No systemic disease (cardiovascular, renal, hepatic) that would preclude surgery. No other severe incapacitating disease:

    • ASA IV: A patient with severe systemic disease that is a constant threat to life. OR
    • ASA V: A moribund patient who is not expected to survive without the operation.
  9. No concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration
  10. 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.

NOTE: Incompetent patients are not eligible for this trial.

  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: NCT00726622

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, California
Cancer Care Center at John Muir Health - Concord Campus
Concord, California, United States, 94524-4110
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, United States, 90027
California Pacific Medical Center - California Campus
San Francisco, California, United States, 94118
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, United States, 94598
United States, Florida
Cleveland Clinic Florida - Weston
Weston, Florida, United States, 33331
United States, Georgia
John B. Amos Cancer Center
Columbus, Georgia, United States, 31904
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Evanston Hospital
Evanston, Illinois, United States, 60201-1781
United States, Indiana
Clarian North Medical Center
Carmel, Indiana, United States, 46032
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Veterans Affairs Medical Center - Indianapolis
Indianapolis, Indiana, United States, 46202
William N. Wishard Memorial Hospital
Indianapolis, Indiana, United States, 46202
Kendrick Regional Center for Colon and Rectal Care - Mooresville
Mooresville, Indiana, United States, 46158
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Massachusetts
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, United States, 01805
United States, Michigan
Blodgett Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49506
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Boone Hospital Center
Columbia, Missouri, United States, 65201
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Overlook Hospital
Summit, New Jersey, United States, 07901
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Stony Brook University Cancer Center
Stony Brook, New York, United States, 11794-9446
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, North Carolina
Duke Cancer Institute
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Oklahoma
INTEGRIS Cancer Institute of Oklahoma - Proton Campus
Oklahoma City, Oklahoma, United States, 73142
United States, Oregon
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
United States, Pennsylvania
Forbes Regional Hospital
Monroeville, Pennsylvania, United States, 15146
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224-1791
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Canada, British Columbia
St. Paul's Hospital at Providence Health Care - Vancouver
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
St. Joseph's Hospital - Charlton Campus
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: James W. Fleshman, MD Baylor Health
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00726622     History of Changes
Other Study ID Numbers: CDR0000601816, ACOSOG-Z6051, U10CA076001, NCI-2009-00350
Study First Received: July 31, 2008
Last Updated: May 13, 2014
Health Authority: United States: NCI Central Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
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 August 26, 2014