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

Study Overview
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Brief Summary
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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
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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.

Official Title
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S1316, Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction

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

Intervention / Treatment
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* Procedure: therapeutic conventional surgery
* Procedure: gastrointestinal complications management/prevention
* Other: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (randomized to surgery)<br>Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician. | Procedure: therapeutic conventional surgery<br>* Undergo abdominal surgery<br>Other: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|
| Experimental: Arm II (randomized to non-surgical management)<br>Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician. | Procedure: gastrointestinal complications management/prevention<br>* Undergo non-surgical management<br>* Other names: complications management/prevention, gastrointestinal, management/prevention, gastrointestinal complications;Other: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|
| Experimental: Arm III (no randomization, surgery)<br>Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician as in Arm I. | Procedure: therapeutic conventional surgery<br>* Undergo abdominal surgery<br>Other: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|
| Experimental: Arm IV (no randomization, non-surgical management)<br>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<br>* Undergo non-surgical management<br>* Other names: complications management/prevention, gastrointestinal, management/prevention, gastrointestinal complications;Other: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| NG Tube Use | Use of a nasogastric tube | 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 | 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. | 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. | Assessed at 5 weeks post registration | 
| Overall Survival | Time from date of registration to date of death due to any cause. | From date of registration to maximum of 53 weeks |