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
N/A
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 Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
Site Public Contact
210-450-3800
phoresearchoffice@uthscsa.edu

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

More Details

NCT ID
NCT02270450
Status
Recruiting
Sponsor
Southwest Oncology Group

Study Contact

Veronica Garcia, M.S.
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.