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

Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT02270450
Collaborator
National Cancer Institute (NCI) (NIH), Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
221
38
4
80
5.8
0.1

Study Details

Study Description

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
  • Procedure: therapeutic conventional surgery
  • Procedure: gastrointestinal complications management/prevention
  • Other: quality-of-life assessment
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
221 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 :
Mar 1, 2015
Actual Primary Completion Date :
Apr 1, 2021
Actual Study Completion Date :
Oct 31, 2021

Arms and Interventions

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 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
  • Outcome Measures

    Primary Outcome Measures

    1. Number of days alive and outside the hospital [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 [Up to 1 year]

      The distribution properties of this variable will be examined, and it will be determined whether a normal approximation is adequate, or whether a transformation would be required, or another generalized linear model would be preferable.

    2. Days of nasogastric tube [Up to 1 year]

      The distribution properties of this variable will be examined, and it will be determined whether a normal approximation is adequate, or whether a transformation would be required, or another generalized linear model would be preferable.

    3. Days of intravenous hydration [Up to 1 year]

      The distribution properties of this variable will be examined, and it will be determined whether a normal approximation is adequate, or whether a transformation would be required, or another generalized linear model would be preferable.

    4. Days of solid food [Up to 1 year]

      The distribution properties of this variable will be examined, and it will be determined whether a normal approximation is adequate, or whether a transformation would be required, or another generalized linear model would be preferable.

    5. Overall survival [Up to 1 year]

      The analyses will be based on a Cox regression model with the option of stratifying on study component and selected other key covariates rather than modeling them in the regression.

    6. Total self-reported energy intake [Up to 1 year]

      Macronutrient intake in patients with malignant bowel obstruction (MBO) will be described and relation to time since MBO and if this differs for those undergoing surgery versus no surgery. Similarly, the same associations with the dietary exposure of interest being frequency of meals and alternately composition of meals (liquids, solids, mixed, feeding formulas [oral or enteral]) will be examined.

    Other Outcome Measures

    1. Number of adverse events in patients with ascites [Up to 1 year]

      Treatment effects compared in patients with ascites who undergo surgery vs those treated by non-surgical management.

    2. Number of adverse events in patients with albumin < 3.0 [Up to 1 year]

      Treatment effects compared in patients with albumin < 3.0 who undergo surgery vs those treated by non-surgical management.

    3. Number of adverse events in patients with carcinomatosis evident in more than one quadrant of the abdomen [Up to 1 year]

      Treatment effects compared in patients with carcinomatosis evident in more than one quadrant of the abdomen who undergo surgery vs those treated by non-surgical management.

    4. Diversity of treatment in non-randomized arms (e.g., type of surgical procedure and medications) [Up to 1 year]

      Diversity of treatment includes describing the types of surgical procedures and medications used to treat or manage MBO.

    5. 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 [Up to 1 year]

      Patterns of care includes the frequency with which a patient initially selects one treatment approach and is crossed over to the other strategy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cancer Center at Saint Joseph's Phoenix Arizona United States 85004
    2 Banner University Medical Center - Tucson Tucson Arizona United States 85719
    3 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    4 City of Hope Comprehensive Cancer Center Duarte California United States 91010
    5 Loma Linda University Medical Center Loma Linda California United States 92354
    6 Moffitt Cancer Center Tampa Florida United States 33612
    7 Rush University Medical Center Chicago Illinois United States 60612
    8 University of Kansas Cancer Center Kansas City Kansas United States 66160
    9 UMass Memorial Medical Center - University Campus Worcester Massachusetts United States 01655
    10 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    11 Essentia Health Cancer Center Duluth Minnesota United States 55805
    12 Hackensack University Medical Center Hackensack New Jersey United States 07601
    13 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    14 South Shore University Hospital Bay Shore New York United States 11706
    15 North Shore University Hospital Manhasset New York United States 11030
    16 Long Island Jewish Medical Center New Hyde Park New York United States 11040
    17 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    18 Duke University Medical Center Durham North Carolina United States 27710
    19 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    20 University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania United States 19104
    21 Temple University Hospital Philadelphia Pennsylvania United States 19140
    22 Rhode Island Hospital Providence Rhode Island United States 02903
    23 Medical University of South Carolina Charleston South Carolina United States 29425
    24 Methodist Le Bonheur Germantown Hospital Germantown Tennessee United States 38138
    25 The West Clinic - Wolf River Germantown Tennessee United States 38138
    26 Methodist Hospital Memphis Tennessee United States 38104
    27 University of Tennessee Health Science Center Memphis Tennessee United States 38163
    28 Baylor University Medical Center Dallas Texas United States 75246
    29 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
    30 M D Anderson Cancer Center Houston Texas United States 77030
    31 University Hospital San Antonio Texas United States 78229
    32 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    33 Valley Health / Winchester Medical Center Winchester Virginia United States 22601
    34 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    35 University Health Network-Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
    36 Instituto Nacional De Cancerologia Bogota Colombia 99999
    37 Instituto Nacional De Cancerologia de Mexico Mexico City Tlalpan Mexico 14080
    38 Instituto Nacional de Enfermedades Neoplasicas Lima Peru Lima 34

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT02270450
    Other Study ID Numbers:
    • S1316
    • U10CA037429
    • 1R01HS021491-01A1
    • S1316
    • NCI-2014-01497
    First Posted:
    Oct 21, 2014
    Last Update Posted:
    Apr 29, 2022
    Last Verified:
    Apr 1, 2022
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 29, 2022