S1316, Surgery or Non-Surgical Management in Treating Patients With Intra-Abdominal Cancer and Bowel Obstruction



Status:Recruiting
Conditions:Cancer, Constipation, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:9/2/2018
Start Date:March 2015
End Date:May 2020
Contact:Kimberly Kaberle
Email:kkaberle@swog.org
Phone:2106148808

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S1316, Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction

This partially randomized clinical trial studies surgery or non-surgical management in
treating patients with intra-abdominal cancer and bowel obstruction. Bowel obstruction is a
common problem for advanced cancer patients and can negatively affect quality of life. It is
not yet known whether surgery or non-surgical management is the best treatment option for
bowel obstruction and can lead to better quality of life.


- Patient must have malignant bowel obstruction (MBO) as evidenced by all of the
following:

- Clinical evidence of a bowel obstruction (via history, physical, and radiographic
examination)

- Bowel obstruction below (distal to) ligament of Treitz

- Intra-abdominal primary cancer with incurable disease

- Patients must have malignant bowel obstruction due to an intra-abdominal primary
cancer (i.e. stomach, small bowel [including duodenum], pancreas, colon, rectum,
appendiceal, ovarian, uterine, cervical, kidney, bladder, prostate, gastrointestinal
stromal tumor [GIST] [all sites], and sarcoma)

- Patient must be able to tolerate a major surgical procedure based on clinical
evaluation, status of their cancer, and any other underlying medical problems

- A member of the patient's surgical team must indicate equipoise for the benefit of the
surgical treatment for MBO; the surgeon must respond "Yes" to each of the following
questions and sign the S1316 Surgical Equipoise Documentation form for the patient to
be eligible:

- Is surgery for treatment of malignant bowel obstruction (MBO) being considered
for this patient?

- Do you have equipoise (If the treating team finds that an operation is required
[e.g., for acute abdomen], or they would not offer the patient an operation
[e.g., patient is too weak to tolerate surgery], then there is no equipoise)?

- Patients must not have signs of bowel perforation or "acute" abdomen as evidenced by
free air on radiologic imaging or peritonitis on physical exam within 2 days prior to
registration

- Patients must be registered to the study within 3 days after surgical consult for MBO
and prior to any treatment (surgical or non-surgical) for MBO

- Patients must have Zubrod performance status of 0-2 within 7 days prior to
registration

- Serum albumin must be planned to be collected after admission, but prior to treatment

- Patients must be able to complete the study questionnaires in English

- Patients or their legally authorized representative must be informed of the
investigational nature of this study and must sign and give written informed consent
in accordance with institutional and federal guidelines

- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the
treating institution's identity is provided in order to ensure that the current
(within 365 days) date of institutional review board approval for this study has been
entered in the system

- Patients must consent and provide both their contact information and that of their
representative for a monthly 24-hour dietary recall phone call to be conducted by the
Arizona Diet, Behavior and Quality of Life Assessment Lab
We found this trial at
35
sites
Memphis, Tennessee 38163
Principal Investigator: Jeremiah L. Deneve
Phone: 901-448-3303
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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Albuquerque, NM
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Principal Investigator: Jeffrey P. Lamont
Phone: 800-422-9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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Duarte, CA
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Jonathan A. Laryea
Phone: 501-686-8274
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
Principal Investigator: Gary B. Deutsch
Phone: 516-734-8896
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Thomas J. Miner
Phone: 401-444-1488
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Mio Kitano
Phone: 210-450-3800
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
Principal Investigator: Phillip E. Rodgers
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Bay Shore, New York 11706
Principal Investigator: Gary B. Deutsch
Phone: 516-734-8896
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Whitney S. Graybill
Phone: 843-792-9321
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Summer B. Dewdney
Phone: 312-942-7261
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Duluth, Minnesota 55805
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Angeles A. Secord
Phone: 888-275-3853
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Germantown, Tennessee 38138
Principal Investigator: Jeremiah L. Deneve
Phone: 901-516-2579
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Germantown, Tennessee 38138
Principal Investigator: Jeremiah L. Deneve
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Marson T. Davidson
Phone: 201-996-2879
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Houston, Texas 77030
Principal Investigator: Eric J. Silberfein
Phone: 713-798-1354
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Houston, Texas 77030
Principal Investigator: Brian D. Badgwell
Phone: 877-312-3961
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Kansas City, Kansas 66160
Principal Investigator: Mazin F. Al-kasspooles
Phone: 913-945-7552
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Maheswari Senthil
Phone: 909-558-3375
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Memphis, Tennessee 38104
Principal Investigator: Jeremiah L. Deneve
Phone: 901-516-2579
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
Principal Investigator: Harveshp D. Mogal
Phone: 414-805-4380
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
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270-05 76th Ave
New Hyde Park, New York 11040
(718) 470-7480
Principal Investigator: Gary B. Deutsch
Phone: 516-734-8896
Long Island Jewish Medical Center Serving North Shore LIJ Health System employees and their families....
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Camille Gunderson
Phone: 405-271-8777
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Philadelphia, Pennsylvania 19104
Principal Investigator: Giorgos C. Karakousis
Phone: 800-474-9892
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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Phoenix, Arizona 85004
Principal Investigator: David Row
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San Antonio, Texas 78229
Principal Investigator: Mio Kitano
Phone: 210-358-4176
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Tampa, Florida 33612
Principal Investigator: Jose M. Pimiento Echeverry
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Toronto, Ontario
Principal Investigator: Alexandra M. Easson
Phone: 416-946-4501
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Tucson, Arizona 85724
Principal Investigator: Valentine N. Nfonsam
Phone: 520-626-9008
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Winchester, Virginia 22601
Principal Investigator: Devin Flaherty
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55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Principal Investigator: Giles F. Whalen
Phone: 508-856-3216
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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