Clinical trial NCT02270450: 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
Overall status: COMPLETED
Phase: NA
Conditions: Constipation, Impaction, and Bowel Obstruction
Unspecified Adult Solid Tumor, Protocol Specific
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2014-10-21
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of Days Alive and Outside of the Hospital
timeFrame: From date of registration up to 91 days
Secondary outcomes:
measure: Number of Days in Hospital
timeFrame: During initial hospitalization, from date of registration to a maximum of 53 weeks post registration
measure: NG Tube Use
timeFrame: During initial hospitalization, from date of registration to a maximum of 53 weeks post registration
measure: Days of NG Tube Use
timeFrame: During entire initial hospitalization (admission to discharge) to a maximum of 53 weeks post registration
measure: MDASI-GI Symptom Assessment
timeFrame: Assessed at 4 weeks post registration
measure: Ability to Eat
timeFrame: Assessed at 5 weeks post registration
measure: Overall Survival
timeFrame: From date of registration to maximum of 53 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Cancer Center at Saint Joseph's
state: Arizona
city: Tucson
country: United States
facility: Banner University Medical Center - Tucson
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Worcester
country: United States
facility: UMass Memorial Medical Center - University Campus
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Duluth
country: United States
facility: Essentia Health Cancer Center
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Bay Shore
country: United States
facility: South Shore University Hospital
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania/Abramson Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Germantown
country: United States
facility: Methodist Le Bonheur Germantown Hospital
state: Tennessee
city: Germantown
country: United States
facility: The West Clinic - Wolf River
state: Tennessee
city: Memphis
country: United States
facility: Methodist Hospital
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: University Hospital
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Winchester
country: United States
facility: Valley Health / Winchester Medical Center
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Toronto
country: Canada
facility: University Health Network-Princess Margaret Hospital
state: Ontario
city: Bogota
country: Colombia
facility: Instituto Nacional De Cancerologia
city: Mexico City
country: Mexico
facility: Instituto Nacional De Cancerologia de Mexico
state: Tlalpan
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
Study officials:
affiliation: University of Arizona
name: Robert S Krouse, M.D., F.A.C.S.
role: STUDY_CHAIR
References: