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

NCT02270450 | Completed Results DMC

• 4 other identifiers: S1316U10CA0374291R01HS021491-01A1NCI-2014-01497
• Study Type: interventional
• Target: 221
• Locations: 5 countries
• Sites: 38

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of Days in Hospital

  During initial hospitalization, from date of registration to a maximum of 53 weeks post registration

• NG Tube Use

  During initial hospitalization, from date of registration to a maximum of 53 weeks post registration

• Days of NG Tube Use

  During entire initial hospitalization (admission to discharge) to a maximum of 53 weeks post registration

• MDASI-GI Symptom Assessment

  Assessed at 4 weeks post registration

• Ability to Eat

  Assessed at 5 weeks post registration

Study Arms (4)

Arm I (randomized to surgery)

EXPERIMENTAL

Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.

Procedure: therapeutic conventional surgery; Other: quality-of-life assessment

Arm II (randomized to non-surgical management)

EXPERIMENTAL

Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.

Procedure: gastrointestinal complications management/prevention; Other: quality-of-life assessment

Arm III (no randomization, surgery)

EXPERIMENTAL

Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician as in Arm I.

Procedure: therapeutic conventional surgery; Other: quality-of-life assessment

Arm IV (no randomization, non-surgical management)

EXPERIMENTAL

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; Other: quality-of-life assessment

Interventions

therapeutic conventional surgery PROCEDURE

Undergo abdominal surgery

Arm I (randomized to surgery); Arm III (no randomization, surgery)

gastrointestinal complications management/prevention PROCEDURE

Undergo non-surgical management

Also known as: complications management/prevention, gastrointestinal, management/prevention, gastrointestinal complications

Arm II (randomized to non-surgical management); Arm IV (no randomization, non-surgical management)

quality-of-life assessment OTHER

Ancillary studies

Also known as: quality of life assessment

Arm I (randomized to surgery); Arm II (randomized to non-surgical management); Arm III (no randomization, surgery); Arm IV (no randomization, non-surgical management)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (38)

Cancer Center at Saint Joseph's

Phoenix, Arizona, 85004, United States

Location

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Essentia Health Cancer Center

Duluth, Minnesota, 55805, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87102, United States

Location

South Shore University Hospital

Bay Shore, New York, 11706, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Methodist Le Bonheur Germantown Hospital

Germantown, Tennessee, 38138, United States

Location

The West Clinic - Wolf River

Germantown, Tennessee, 38138, United States

Location

Methodist Hospital

Memphis, Tennessee, 38104, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University Hospital

San Antonio, Texas, 78229, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Valley Health / Winchester Medical Center

Winchester, Virginia, 22601, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Instituto Nacional De Cancerologia

Bogotá, 99999, Colombia

Location

Instituto Nacional De Cancerologia de Mexico

Mexico City, Tlalpan, 14080, Mexico

Location

Instituto Nacional de Enfermedades Neoplasicas

Lima, Lima 34, Peru

Location

Related Publications (1)

• Krouse RS, Anderson GL, Arnold KB, Thomson CA, Nfonsam VN, Al-Kasspooles MF, Walker JL, Sun V, Alvarez Secord A, Han ES, Leon-Takahashi AM, Isla-Ortiz D, Rodgers P, Hendren S, Sanchez Salcedo M, Laryea JA, Graybill WS, Flaherty DC, Mogal H, Miner TJ, Pimiento JM, Kitano M, Badgwell B, Whalen G, Lamont JP, Guevara OA, Senthil MS, Dewdney SB, Silberfein E, Wright JD, Friday B, Fahy B, Anantha Sathyanarayana S, O'Rourke M, Bakitas M, Sloan J, Grant M, Deutsch GB, Deneve JL. Surgical versus non-surgical management for patients with malignant bowel obstruction (S1316): a pragmatic comparative effectiveness trial. Lancet Gastroenterol Hepatol. 2023 Oct;8(10):908-918. doi: 10.1016/S2468-1253(23)00191-7. Epub 2023 Aug 1.

  PMID: 37541263 DERIVED

MeSH Terms

Conditions

Constipation; Intestinal Obstruction

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Palliative and End of Life Care Committee Statistician
• Organization: SWOG Statistics and Data Management Center

karnold@fredhutch.org

2066674623

Study Officials

• Robert S Krouse, M.D., F.A.C.S.

  University of Arizona

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 21, 2014
• Study Start: March 9, 2015
• Primary Completion: April 1, 2021
• Study Completion: October 31, 2021
• Last Updated: March 30, 2023
• Results First Posted: November 21, 2022

Record last verified: 2022-11

Locations

PE (1); CO (1); US (34); CA (1); ME (1)