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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

S1316, Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270450
• Other study ID #: S1316
• Secondary ID: U10CA0374291R01H
• Status: Completed
• Phase: N/A
• Start date: March 9, 2015
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2022
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: October 31, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Constipation
• Constipation, Impaction, and Bowel Obstruction
• Intestinal Obstruction
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Procedure:
• therapeutic conventional surgery
Undergo abdominal surgery
• gastrointestinal complications management/prevention
Undergo non-surgical management

Other:
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
Canada	University Health Network-Princess Margaret Hospital	Toronto	Ontario
Colombia	Instituto Nacional De Cancerologia	Bogota
Mexico	Instituto Nacional De Cancerologia de Mexico	Mexico City	Tlalpan
Peru	Instituto Nacional de Enfermedades Neoplasicas	Lima
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	South Shore University Hospital	Bay Shore	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	Baylor University Medical Center	Dallas	Texas
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Essentia Health Cancer Center	Duluth	Minnesota
United States	Duke University Medical Center	Durham	North Carolina
United States	Methodist Le Bonheur Germantown Hospital	Germantown	Tennessee
United States	The West Clinic - Wolf River	Germantown	Tennessee
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center	Houston	Texas
United States	M D Anderson Cancer Center	Houston	Texas
United States	University of Kansas Cancer Center	Kansas City	Kansas
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Loma Linda University Medical Center	Loma Linda	California
United States	North Shore University Hospital	Manhasset	New York
United States	Methodist Hospital	Memphis	Tennessee
United States	University of Tennessee Health Science Center	Memphis	Tennessee
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center	New York	New York
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania/Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Cancer Center at Saint Joseph's	Phoenix	Arizona
United States	Rhode Island Hospital	Providence	Rhode Island
United States	University Hospital	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Moffitt Cancer Center	Tampa	Florida
United States	Banner University Medical Center - Tucson	Tucson	Arizona
United States	Valley Health / Winchester Medical Center	Winchester	Virginia
United States	UMass Memorial Medical Center - University Campus	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Southwest Oncology Group	Agency for Healthcare Research and Quality (AHRQ), National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Colombia,  Mexico,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	NG Tube Use	Use of a nasogastric tube	During initial hospitalization, from date of registration to a maximum of 53 weeks post registration
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall Survival	Time from date of registration to date of death due to any cause.	From date of registration to maximum of 53 weeks