Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria


- 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm I (randomized to surgery)
Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.
  • Procedure: therapeutic conventional surgery
    Undergo abdominal surgery
  • Other: quality-of-life assessment
    Ancillary studies
    Other names:
    • quality of life assessment
Experimental
Arm II (randomized to non-surgical management)
Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.
  • Procedure: gastrointestinal complications management/prevention
    Undergo non-surgical management
    Other names:
    • complications management/prevention, gastrointestinal, management/prevention, gastrointestinal complications
  • Other: quality-of-life assessment
    Ancillary studies
    Other names:
    • quality of life assessment
Experimental
Arm III (no randomization, surgery)
Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician as in Arm I.
  • Procedure: therapeutic conventional surgery
    Undergo abdominal surgery
  • Other: quality-of-life assessment
    Ancillary studies
    Other names:
    • quality of life assessment
Experimental
Arm IV (no randomization, non-surgical management)
Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm II.
  • Procedure: gastrointestinal complications management/prevention
    Undergo non-surgical management
    Other names:
    • complications management/prevention, gastrointestinal, management/prevention, gastrointestinal complications
  • Other: quality-of-life assessment
    Ancillary studies
    Other names:
    • quality of life assessment

Recruiting Locations

University of Arizona Cancer Center at Saint Joseph's
Phoenix, Arizona 85004
Contact:
David Row
protocols@swog.org

The University of Arizona Medical Center-University Campus
Tucson, Arizona 85724
Contact:
Valentine N. Nfonsam
520-626-9008

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Jonathan A. Laryea
501-686-8274

Loma Linda University Medical Center
Loma Linda, California 92354
Contact:
Maheswari Senthil
909-558-3375

Moffitt Cancer Center
Tampa, Florida 33612
Contact:
Jose M. Pimiento Echeverry
protocols@swog.org

University of Kansas Cancer Center
Kansas City, Kansas 66160
Contact:
Mazin F. Al-kasspooles
913-945-7552
ctnursenav@kumc.edu

University of Massachusetts Medical School
Worcester, Massachusetts 01655
Contact:
Giles F. Whalen
508-856-3216
cancer.research@umassmed.edu

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
Contact:
Phillip E. Rodgers
800-865-1125

Essentia Health Cancer Center
Duluth, Minnesota 55805
Contact:
Bret E. Friday
888-203-7267

Hackensack University Medical Center
Hackensack, New Jersey 07601
Contact:
Marson T. Davidson
201-996-2879

Southside Hospital
Bay Shore, New York 11706
Contact:
Gary B. Deutsch
516-734-8954
vvincigu@northwell.edu

North Shore University Hospital
Manhasset, New York 11030
Contact:
Gary B. Deutsch
516-734-8954
vvincigu@northwell.edu

Long Island Jewish Medical Center
New Hyde Park, New York 11040
Contact:
Gary B. Deutsch
516-734-8954
vvincigu@northwell.edu

Duke University Medical Center
Durham, North Carolina 27710
Contact:
Angeles A. Secord
888-275-3853

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Camille Gunderson
405-271-8777
ou-clinical-trials@ouhsc.edu

University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania 19104
Contact:
Giorgos C. Karakousis
800-474-9892

Rhode Island Hospital
Providence, Rhode Island 02903
Contact:
Thomas J. Miner
401-444-1488

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Whitney S. Graybill
843-792-9321

The West Clinic - Wolf River
Germantown, Tennessee 38138
Contact:
Jeremiah L. Deneve
901-516-2579

Methodist Hospital
Memphis, Tennessee 38104
Contact:
Jeremiah L. Deneve
901-516-2579

University of Tennessee Health Science Center
Memphis, Tennessee 38163
Contact:
Jeremiah L. Deneve
901-516-2579

Baylor University Medical Center
Dallas, Texas 75246
Contact:
Jeffrey P. Lamont
800-422-9567

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77030
Contact:
Eric J. Silberfein
713-798-1354
burton@bcm.edu

M D Anderson Cancer Center
Houston, Texas 77030
Contact:
Brian D. Badgwell
713-792-3245

University Hospital
San Antonio, Texas 78229
Contact:
Mio Kitano
210-358-4176
evelyn.swenson-britt@uhs-sa.com

University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
Mio Kitano
210-450-3800
CTO@uthscsa.edu

Valley Health / Winchester Medical Center
Winchester, Virginia 22601
Contact:
Devin Flaherty
protocols@swog.org

Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Harveshp D. Mogal
414-805-4380

More Details

NCT ID
NCT02270450
Status
Recruiting
Sponsor
Southwest Oncology Group

Study Contact

Kimberly Kaberle
2106148808
kkaberle@swog.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.