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

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ClinicalTrials.gov Identifier: NCT02270450
Recruitment Status : Recruiting
First Posted : October 21, 2014
Last Update Posted : August 31, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Constipation, Impaction, and Bowel Obstruction Unspecified Adult Solid Tumor, Protocol Specific Procedure: therapeutic conventional surgery Procedure: gastrointestinal complications management/prevention Other: quality-of-life assessment Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: S1316, Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction
Study Start Date : March 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 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 Name: complications management/prevention, gastrointestinal, management/prevention, gastrointestinal complications

Other: quality-of-life assessment
Ancillary studies
Other Name: 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 Name: 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 Name: complications management/prevention, gastrointestinal, management/prevention, gastrointestinal complications

Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment




Primary Outcome Measures :
  1. Number of days alive and outside the hospital [ Time Frame: Within the first 91 days after enrollment ]
    The primary analysis will pool data from both components using a multivariate linear regression model, including a parameter for study component. Factors considered likely to confound the association of treatment and outcome in the non-randomized component will be carefully modeled in the regression. Potential residual bias in the treatment group comparison from the non-randomized component will be assessed by estimating the interaction term between treatment group and study component (randomized vs. non-randomized).


Secondary Outcome Measures :
  1. Ability to eat [ Time Frame: Up to 1 year ]
  2. Days of nasogastric tube [ Time Frame: Up to 1 year ]
  3. Days of intravenous hydration [ Time Frame: Up to 1 year ]
  4. Days of solid food [ Time Frame: Up to 1 year ]
  5. Overall survival [ Time Frame: Up to 1 year ]
  6. Total self-reported energy intake [ Time Frame: Up to 1 year ]

Other Outcome Measures:
  1. Number of adverse events in patients with ascites [ Time Frame: Up to 1 year ]
  2. Number of adverse events in patients with albumin < 3.0 [ Time Frame: Up to 1 year ]
  3. Number of adverse events in patients with carcinomatosis evident in more than one quadrant of the abdomen [ Time Frame: Up to 1 year ]
  4. Predictors of treatment in non-randomized arms [ Time Frame: Up to 1 year ]
    To explore whether there are clinical factors (ascites, albumin, carcinomatosis) that will predict better quality of life outcomes for patients with malignant bowel obstruction who receive surgical intervention as compared to non-surgical intervention.

  5. Diversity of treatment in non-randomized arms (e.g., type of surgical procedure and medications) [ Time Frame: Up to 1 year ]
  6. Patterns of care over time in non-randomized arms, including frequency with which a patient initially selects one treatment approach is crossed over to the other strategy [ Time Frame: Up to 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270450


Contacts
Contact: Kimberly Kaberle 2106148808 ext 1022 kkaberle@swog.org
Contact: Dana Sparks, M.A.T. 2106148808 ext 1004 dsparks@swog.org

  Show 37 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Study Chair: Robert S Krouse, M.D., F.A.C.S. University of Arizona

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT02270450     History of Changes
Other Study ID Numbers: S1316
U10CA037429 ( U.S. NIH Grant/Contract )
1R01HS021491-01A1 ( U.S. AHRQ Grant/Contract )
S1316 ( Other Identifier: SWOG )
NCI-2014-01497 ( Other Identifier: NCI )
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Constipation
Intestinal Obstruction
Signs and Symptoms, Digestive
Signs and Symptoms
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases