Back to resultsS1316, Surgery or Non-Surgical Management in Treating Patients With Intra-Abdominal Cancer and Bowel Obstruction
Primary Purpose
Constipation, Impaction, and Bowel Obstruction, Unspecified Adult Solid Tumor, Protocol Specific
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
therapeutic conventional surgery
gastrointestinal complications management/prevention
quality-of-life assessment
Sponsored by
About this trial
This is an interventional supportive care trial for Constipation, Impaction, and Bowel Obstruction
Eligibility 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
Sites / Locations
- Cancer Center at Saint Joseph's
- Banner University Medical Center - Tucson
- University of Arkansas for Medical Sciences
- City of Hope Comprehensive Cancer Center
- Loma Linda University Medical Center
- Moffitt Cancer Center
- Rush University Medical Center
- University of Kansas Cancer Center
- UMass Memorial Medical Center - University Campus
- University of Michigan Comprehensive Cancer Center
- Essentia Health Cancer Center
- Hackensack University Medical Center
- University of New Mexico Cancer Center
- South Shore University Hospital
- North Shore University Hospital
- Long Island Jewish Medical Center
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- Duke University Medical Center
- University of Oklahoma Health Sciences Center
- University of Pennsylvania/Abramson Cancer Center
- Temple University Hospital
- Rhode Island Hospital
- Medical University of South Carolina
- Methodist Le Bonheur Germantown Hospital
- The West Clinic - Wolf River
- Methodist Hospital
- University of Tennessee Health Science Center
- Baylor University Medical Center
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- M D Anderson Cancer Center
- University Hospital
- University of Texas Health Science Center at San Antonio
- Valley Health / Winchester Medical Center
- Medical College of Wisconsin
- University Health Network-Princess Margaret Hospital
- Instituto Nacional De Cancerologia
- Instituto Nacional De Cancerologia de Mexico
- Instituto Nacional de Enfermedades Neoplasicas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Arm I (randomized to surgery)
Arm II (randomized to non-surgical management)
Arm III (no randomization, surgery)
Arm IV (no randomization, non-surgical management)
Arm Description
Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.
Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.
Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician as in Arm I.
Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm II.
Outcomes
Primary Outcome Measures
Number of Days Alive and Outside of the Hospital
Number of days alive and outside of the hospital
Secondary Outcome Measures
Number of Days in Hospital
Length of initial hospital stay in days.
NG Tube Use
Use of a nasogastric tube
Days of NG Tube Use
Number of days a nasogastric tube was used during the patient's initial hospitalization
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.
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.
Overall Survival
Time from date of registration to date of death due to any cause.
Full Information
NCT ID
NCT02270450
First Posted
October 10, 2014
Last Updated
March 28, 2023
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI), Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT02270450
Brief Title
S1316, Surgery or Non-Surgical Management in Treating Patients With Intra-Abdominal Cancer and Bowel Obstruction
Official Title
S1316, Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 9, 2015 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI), Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Impaction, and Bowel Obstruction, Unspecified Adult Solid Tumor, Protocol Specific
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
221 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I (randomized to surgery)
Arm Type
Experimental
Arm Description
Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.
Arm Title
Arm II (randomized to non-surgical management)
Arm Type
Experimental
Arm Description
Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.
Arm Title
Arm III (no randomization, surgery)
Arm Type
Experimental
Arm Description
Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician as in Arm I.
Arm Title
Arm IV (no randomization, non-surgical management)
Arm Type
Experimental
Arm Description
Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm II.
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Description
Undergo abdominal surgery
Intervention Type
Procedure
Intervention Name(s)
gastrointestinal complications management/prevention
Other Intervention Name(s)
complications management/prevention, gastrointestinal, management/prevention, gastrointestinal complications
Intervention Description
Undergo non-surgical management
Intervention Type
Other
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Number of Days Alive and Outside of the Hospital
Description
Number of days alive and outside of the hospital
Time Frame
From date of registration up to 91 days
Secondary Outcome Measure Information:
Title
Number of Days in Hospital
Description
Length of initial hospital stay in days.
Time Frame
During initial hospitalization, from date of registration to a maximum of 53 weeks post registration
Title
NG Tube Use
Description
Use of a nasogastric tube
Time Frame
During initial hospitalization, from date of registration to a maximum of 53 weeks post registration
Title
Days of NG Tube Use
Description
Number of days a nasogastric tube was used during the patient's initial hospitalization
Time Frame
During entire initial hospitalization (admission to discharge) to a maximum of 53 weeks post registration
Title
MDASI-GI Symptom Assessment
Description
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.
Time Frame
Assessed at 4 weeks post registration
Title
Ability to Eat
Description
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.
Time Frame
Assessed at 5 weeks post registration
Title
Overall Survival
Description
Time from date of registration to date of death due to any cause.
Time Frame
From date of registration to maximum of 53 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Krouse, M.D., F.A.C.S.
Organizational Affiliation
University of Arizona
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Center at Saint Joseph's
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Banner University Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
UMass Memorial Medical Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Essentia Health Cancer Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
South Shore University Hospital
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Pennsylvania/Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Methodist Le Bonheur Germantown Hospital
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
The West Clinic - Wolf River
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Methodist Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Valley Health / Winchester Medical Center
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
University Health Network-Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Instituto Nacional De Cancerologia
City
Bogota
ZIP/Postal Code
99999
Country
Colombia
Facility Name
Instituto Nacional De Cancerologia de Mexico
City
Mexico City
State/Province
Tlalpan
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Instituto Nacional de Enfermedades Neoplasicas
City
Lima
ZIP/Postal Code
Lima 34
Country
Peru
12. IPD Sharing Statement
Learn more about this trial
S1316, Surgery or Non-Surgical Management in Treating Patients With Intra-Abdominal Cancer and Bowel Obstruction
We'll reach out to this number within 24 hrs