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



Status:Active, not recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/10/2018
Start Date:August 2008

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A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Resection Versus Open Resection for Rectal Cancer

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.

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 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.
We found this trial at
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Columbia, Missouri 65201
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675 N Saint Clair St # 21-100
Chicago, Illinois 60611
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Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
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2010 E 90th St
Cleveland, Ohio 44195
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Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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200 Hawkins Drive
Iowa City, Iowa 52242
800-237-1225
Holden Comprehensive Cancer Center at University of Iowa Holden Comprehensive Cancer Center is dedicated to...
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4800 Friendship Avenue
Pittsburgh, Pennsylvania 15224
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750 E Adams St
Syracuse, New York 13210
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Burlington, Massachusetts 01805
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Carmel, Indiana 46032
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1831 Fifth Avenue
Columbus, Georgia 31904
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John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
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20 Duke Clinic Cir
Durham, North Carolina 27710
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Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
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2650 Ridge Ave.
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Grand Rapids, Michigan 49506
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Indianapolis, Indiana 46202
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535 Barnhill Dr
Indianapolis, Indiana 46202
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Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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Los Angeles, California 90027
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8800 W. Doyne Avenue
Milwaukee, Wisconsin 53226
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Monroeville, Pennsylvania 15146
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1275 York Ave
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4805 NE Glisan St
Portland, Oregon 97213
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Providence Cancer Center at Providence Portland Medical Center We strive to give those we serve...
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200 First Street SW
Rochester, Minnesota 55905
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3700 California Street
San Francisco, California 94118
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California Pacific Medical Center - California Campus California Pacific Medical Center is one of the...
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5777 E Mayo Blvd
Scottsdale, Arizona 85259
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3 Edmund D. Pellegrino Road
Stony Brook, New York 11794
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Stony Brook University Cancer Center Ask a cancer survivor. Having highly advanced care close to...
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99 Beauvoir Avenue
Summit, New Jersey 07902
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Overlook Hospital Atlantic Health System
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Weston, Florida 33331
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100 E Lancaster Ave
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