A Phase III Prospective Randomized Trial Comparing Laparoscopic-assisted Resection Versus Open Resection for Rectal Cancer
18 Years
N/A
Both
Colorectal Cancer
Trial Information
A Phase III Prospective Randomized Trial Comparing Laparoscopic-assisted Resection Versus Open Resection for Rectal Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Circumferential margin > 1 mm
Safety Issue:
No
Principal Investigator
James W. Fleshman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Washington University Siteman Cancer Center
Authority:
Unspecified
Study ID:
CDR0000601816
NCT ID:
NCT00726622
Start Date:
August 2008
Completion Date:
Related Keywords:
- Colorectal Cancer
- stage IIA rectal cancer
- stage IIIA rectal cancer
- stage IIIB rectal cancer
- adenocarcinoma of the rectum
- Rectal Neoplasms
- Colorectal Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
| Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
| Kaiser Permanente Medical Center - Los Angeles | Los Angeles, California 90027 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Overlook Hospital | Summit, New Jersey 07902-0220 |
| Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
| SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
| Lahey Clinic Medical Center - Burlington | Burlington, Massachusetts 01805 |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
| M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
| California Pacific Medical Center - California Campus | San Francisco, California 94118 |
| John Muir/Mt. Diablo Comprehensive Cancer Center | Walnut Creek, California 94598 |
| Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
| Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh, Pennsylvania 15212 |
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224-1791 |
| John B. Amos Cancer Center | Columbus, Georgia 31904 |
| Evanston Hospital | Evanston, Illinois 60201-1781 |
| William N. Wishard Memorial Hospital | Indianapolis, Indiana 46202 |
| Duke Cancer Institute | Durham, North Carolina 27710 |
| Veterans Affairs Medical Center - Indianapolis | Indianapolis, Indiana 46202 |
| Cleveland Clinic Florida - Weston | Weston, Florida 33331 |
| Cancer Care Center at John Muir Health - Concord Campus | Concord, California 94524-4110 |
| Boone Hospital Center | Columbia, Missouri 65201 |
| Kendrick Regional Center for Colon and Rectal Care - Mooresville | Mooresville, Indiana 46158 |
| Blodgett Hospital at Spectrum Health | Grand Rapids, Michigan 49506 |
| INTEGRIS Cancer Institute of Oklahoma - Proton Campus | Oklahoma City, Oklahoma 73142 |
| Forbes Regional Hospital | Monroeville, Pennsylvania 15146 |
| Clarian North Medical Center | Carmel, Indiana 46032 |
