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

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.

Study Overview

• Status: Completed
• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Constipation, Impaction, and Bowel Obstruction
• Intervention / Treatment: Other: quality-of-life assessment; Procedure: therapeutic conventional surgery; Procedure: gastrointestinal complications management/prevention

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 Type: Interventional
• Enrollment (Actual): 221
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network-Princess Margaret Hospital
• Colombia
  • Bogota, Colombia, 99999
    • Instituto Nacional de Cancerologia
• Mexico
  • Tlalpan
    • Mexico City, Tlalpan, Mexico, 14080
      • Instituto Nacional De Cancerologia de Mexico
• Peru
  • Lima, Peru, Lima 34
    • Instituto Nacional de Enfermedades Neoplasicas
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Cancer Center at Saint Joseph's
    • Tucson, Arizona, United States, 85719
      • Banner University Medical Center - Tucson
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • California
    • Duarte, California, United States, 91010
      • City of Hope Comprehensive Cancer Center
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Cancer Center
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center - University Campus
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Comprehensive Cancer Center
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Essentia Health Cancer Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • University of New Mexico Cancer Center
  • New York
    • Bay Shore, New York, United States, 11706
      • South Shore University Hospital
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New Hyde Park, New York, United States, 11040
      • Long Island Jewish Medical Center
    • New York, New York, United States, 10032
      • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania/Abramson Cancer Center
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The West Clinic - Wolf River
    • Germantown, Tennessee, United States, 38138
      • Methodist Le Bonheur Germantown Hospital
    • Memphis, Tennessee, United States, 38163
      • University of Tennessee Health Science Center
    • Memphis, Tennessee, United States, 38104
      • Methodist Hospital
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
    • San Antonio, Texas, United States, 78229
      • University Hospital
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio
  • Virginia
    • Winchester, Virginia, United States, 22601
      • Valley Health / Winchester Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Days Alive and Outside of the Hospital	Number of days alive and outside of the hospital	From date of registration up to 91 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Days in Hospital	Length of initial hospital stay in days.	During initial hospitalization, from date of registration to a maximum of 53 weeks post registration
NG Tube Use	Use of a nasogastric tube	During initial hospitalization, from date of registration to a maximum of 53 weeks post registration
Days of NG Tube Use	Number of days a nasogastric tube was used during the patient's initial hospitalization	During entire initial hospitalization (admission to discharge) to a maximum of 53 weeks post registration
MDASI-GI Symptom Assessment	The MD Anderson Symptom Inventory for gastrointestinal cancer (MDASI-GI) was used to assess nausea, vomiting, pain, bloating, and constipation. The MDASI measures symptom severity on an 11-point scale, from 0 ("not present") to 10 ("as bad as you can imagine"). A difference of at least 1.2 points was considered a clinically meaningful difference between groups for MDASI-GI outcomes.	Assessed at 4 weeks post registration
Ability to Eat	Ability to consume food was assessed based on self or caregiver-reported 24-hour dietary recalls. Dietary recalls were collected by trained assessors at the University of Arizona Cancer Center Behavioral Measurement and Interventions Shared Resource (BMISR) via telephone using standardized protocols and Nutrient Database for Research.	Assessed at 5 weeks post registration
Overall Survival	Time from date of registration to date of death due to any cause.	From date of registration to maximum of 53 weeks

Collaborators and Investigators

• Sponsor: Southwest Oncology Group
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): March 9, 2015
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: October 10, 2014
• First Submitted That Met QC Criteria: October 17, 2014
• First Posted (Estimate): October 21, 2014

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Intestinal Diseases; Constipation; Intestinal Obstruction
• Other Study ID Numbers: S1316 (Other Identifier: SWOG); U10CA037429 (U.S. NIH Grant/Contract); 1R01HS021491-01A1 (U.S. AHRQ Grant/Contract); NCI-2014-01497 (Other Identifier: NCI)