Constipation, Impaction, and Bowel ObstructionNCT02270450

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

A study testing therapeutic conventional surgery, gastrointestinal complications management/prevention and quality-of-life assessment in people with Constipation, Impaction, and Bowel Obstruction and Unspecified Adult Solid Tumor, Protocol Specific, run by SWOG Cancer Research Network at 38 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Constipation, Impaction, and Bowel Obstruction, Unspecified Adult Solid Tumor, Protocol Specific
What is being tested?: therapeutic conventional surgery, gastrointestinal complications management/prevention and quality-of-life assessment
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 221 participants
Where: 38 sitesin 5 countries
Study dates: 9 Mar 2015to 31 Oct 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

38 sites in 5 countries.

Country

City, postcode or hospital

38 sites in 5 countries

United States34 sites

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

Other trials in United States

Canada1 site

University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9

Other trials in Canada

Colombia1 site

Instituto Nacional De Cancerologia
Bogotá, 99999

Other trials in Colombia

Mexico1 site

Instituto Nacional De Cancerologia de Mexico
Mexico City, Tlalpan, 14080

Other trials in Mexico

Peru1 site

Instituto Nacional de Enfermedades Neoplasicas
Lima, Lima 34

Other trials in Peru

About this study

Official title: 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.

Read the detailed description

Conditions: Constipation, Impaction, and Bowel Obstruction, Unspecified Adult Solid Tumor, Protocol Specific
Being tested: therapeutic conventional surgery, gastrointestinal complications management/prevention, quality-of-life assessment
Medical subject headings: Constipation, Intestinal Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

therapeutic conventional surgeryProcedure or surgery
Undergo abdominal surgery
gastrointestinal complications management/preventionProcedure or surgery
Also called complications management/prevention, gastrointestinal, management/prevention, gastrointestinal complications
Undergo non-surgical management
quality-of-life assessmentOther
Also called quality of life assessment
Ancillary studies

Study groups in NCT02270450
Study group	Role	What they receive
Arm I (randomized to surgery)	Experimental	Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: gastrointestinal complications management/prevention; Other: quality-of-life assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Days Alive and Outside of the Hospital
Number of days alive and outside of the hospital
Measured: From date of registration up to 91 days

Secondary outcomes (6)

Number of Days in Hospital
Length of initial hospital stay in days.
Measured: During initial hospitalization, from date of registration to a maximum of 53 weeks post registration
NG Tube Use
Use of a nasogastric tube
Measured: 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
Measured: 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.
Measured: 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.
Measured: Assessed at 5 weeks post registration
Overall Survival
Time from date of registration to date of death due to any cause.
Measured: From date of registration to maximum of 53 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 201531 Oct 2021

First posted21 Oct 2014 (estimated)
Study start9 Mar 2015
Primary completion1 Apr 2021
Study completion31 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Constipation, Impaction, and Bowel ObstructionStudies of the same condition, open and under way.
More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 221 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02270450
Sponsor's protocol ID: S1316
Other IDs: U10CA037429, 1R01HS021491-01A1, S1316, NCI-2014-01497
Status last verified: Nov 2022
First submitted: 10 Oct 2014
Last updated: 30 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 37541263

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: S1316, Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction
ClinicalTrials.gov ID: NCT02270450
Acronym / sponsor ID: S1316
Conditions: Constipation, Impaction, and Bowel Obstruction, Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Recruitment status: Completed
Enrolment: 221 participants (actual)
Lead sponsor: SWOG Cancer Research NetworkResearch network
Collaborators: National Cancer Institute (NCI), Agency for Healthcare Research and Quality (AHRQ)
Study start: 9 Mar 2015 (actual)
Primary completion: 1 Apr 2021 (actual)
Study completion: 31 Oct 2021 (actual)
First posted: 21 Oct 2014 (estimated)
Results: Posted 21 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Arm I (randomized to surgery)	Experimental	Procedure: therapeutic conventional surgery, Other: quality-of-life assessmentPatients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.
Arm II (randomized to non-surgical management)	Experimental	Procedure: gastrointestinal complications management/prevention, Other: quality-of-life assessmentPatients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.
Arm III (no randomization, surgery)	Experimental	Procedure: therapeutic conventional surgery, Other: quality-of-life assessmentPatients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician as in Arm I.
Arm IV (no randomization, non-surgical management)	Experimental	Procedure: gastrointestinal complications management/prevention, Other: quality-of-life assessmentPatients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm II.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
therapeutic conventional surgeryUndergo abdominal surgery	Procedure or surgery	Arm I (randomized to surgery), Arm III (no randomization, surgery)
gastrointestinal complications management/preventionAlso: complications management/prevention, gastrointestinal, management/prevention, gastrointestinal complicationsUndergo non-surgical management	Procedure or surgery	Arm II (randomized to non-surgical management), Arm IV (no randomization, non-surgical management)
quality-of-life assessmentAlso: quality of life assessmentAncillary studies	Other	Arm I (randomized to surgery), Arm II (randomized to non-surgical management), Arm III (no randomization, surgery), Arm IV (no randomization, non-surgical management)

Primary outcome

Number of Days Alive and Outside of the Hospital
Time frame: From date of registration up to 91 days
Number of days alive and outside of the hospital

6 secondary outcomes

Number of Days in Hospital
Time frame: During initial hospitalization, from date of registration to a maximum of 53 weeks post registration
NG Tube Use
Time frame: During initial hospitalization, from date of registration to a maximum of 53 weeks post registration
Days of NG Tube Use
Time frame: During entire initial hospitalization (admission to discharge) to a maximum of 53 weeks post registration
MDASI-GI Symptom Assessment
Time frame: Assessed at 4 weeks post registration
Ability to Eat
Time frame: Assessed at 5 weeks post registration
Overall Survival
Time frame: From date of registration to maximum of 53 weeks

Results and safety

Results posted to the registry on 21 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I (Randomized to Surgery)	24	1
Arm II (Randomized to Non-surgical Management)	25	3
Arm III (no Randomization, Surgery)	58	18
Arm IV (no Randomization, Non-surgical Management)	92	10

Primary outcome: Number of Days Alive and Outside of the Hospital

Time frame: From date of registration up to 91 days. Mean (Standard Deviation). Unit: days

Measure	Randomization Surgery n = 24	Randomization Non-surgical Management n = 25	Patient Choice Surgery n = 58	Patient Choice Non-surgical Management n = 92
Value	42.6 (32.2)	43.9 (29.5)	54.8 (27.0)	52.7 (30.7)

Randomization Surgery vs Randomization Non-surgical Management vs Patient Choice Surgery vs Patient Choice Non-surgical Management: Mean Difference (Net): 2.87, p = 0.50, Regression, Linear

Population analysed: Eligible and evaluable participants

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From date of registration until death or 53 weeks post registration. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Randomization Surgery	2 of 24 (8.3%)	5 of 24 (20.8%)	19 of 24
Randomization Non-surgical Management	3 of 25 (12%)	1 of 25 (4%)	20 of 25
Patient Choice Surgery	5 of 58 (8.6%)	12 of 58 (20.7%)	37 of 58
Patient Choice Non-surgical Management	16 of 92 (17.4%)	14 of 92 (15.2%)	68 of 92

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37541263Krouse 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert S Krouse, M.D., F.A.C.S. study chair

University of Arizona

38 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Canada, Colombia, Mexico, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Days Alive and Outside of the Hospital (time frame: From date of registration up to 91 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02270450, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.