S1316, Surgery or Non-Surgical Management in Treating Patients With Intra-Abdominal Cancer and Bowel Obstruction
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Arm I (randomized to surgery) Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician. |
Procedure: therapeutic conventional surgery
Undergo abdominal surgery
Other: quality-of-life assessment
Ancillary studies
Other Names:
|
Experimental: Arm II (randomized to non-surgical management) Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician. |
Procedure: gastrointestinal complications management/prevention
Undergo non-surgical management
Other Names:
Other: quality-of-life assessment
Ancillary studies
Other Names:
|
Experimental: Arm III (no randomization, surgery) Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician as in Arm I. |
Procedure: therapeutic conventional surgery
Undergo abdominal surgery
Other: quality-of-life assessment
Ancillary studies
Other Names:
|
Experimental: Arm IV (no randomization, non-surgical management) 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
Undergo non-surgical management
Other Names:
Other: quality-of-life assessment
Ancillary studies
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of days alive and outside the hospital [Within the first 91 days after enrollment]
The primary analysis will pool data from both components using a multivariate linear regression model, including a parameter for study component. Factors considered likely to confound the association of treatment and outcome in the non-randomized component will be carefully modeled in the regression. Potential residual bias in the treatment group comparison from the non-randomized component will be assessed by estimating the interaction term between treatment group and study component (randomized vs. non-randomized).
Secondary Outcome Measures
- Ability to eat [Up to 1 year]
The distribution properties of this variable will be examined, and it will be determined whether a normal approximation is adequate, or whether a transformation would be required, or another generalized linear model would be preferable.
- Days of nasogastric tube [Up to 1 year]
The distribution properties of this variable will be examined, and it will be determined whether a normal approximation is adequate, or whether a transformation would be required, or another generalized linear model would be preferable.
- Days of intravenous hydration [Up to 1 year]
The distribution properties of this variable will be examined, and it will be determined whether a normal approximation is adequate, or whether a transformation would be required, or another generalized linear model would be preferable.
- Days of solid food [Up to 1 year]
The distribution properties of this variable will be examined, and it will be determined whether a normal approximation is adequate, or whether a transformation would be required, or another generalized linear model would be preferable.
- Overall survival [Up to 1 year]
The analyses will be based on a Cox regression model with the option of stratifying on study component and selected other key covariates rather than modeling them in the regression.
- Total self-reported energy intake [Up to 1 year]
Macronutrient intake in patients with malignant bowel obstruction (MBO) will be described and relation to time since MBO and if this differs for those undergoing surgery versus no surgery. Similarly, the same associations with the dietary exposure of interest being frequency of meals and alternately composition of meals (liquids, solids, mixed, feeding formulas [oral or enteral]) will be examined.
Other Outcome Measures
- Number of adverse events in patients with ascites [Up to 1 year]
Treatment effects compared in patients with ascites who undergo surgery vs those treated by non-surgical management.
- Number of adverse events in patients with albumin < 3.0 [Up to 1 year]
Treatment effects compared in patients with albumin < 3.0 who undergo surgery vs those treated by non-surgical management.
- Number of adverse events in patients with carcinomatosis evident in more than one quadrant of the abdomen [Up to 1 year]
Treatment effects compared in patients with carcinomatosis evident in more than one quadrant of the abdomen who undergo surgery vs those treated by non-surgical management.
- Diversity of treatment in non-randomized arms (e.g., type of surgical procedure and medications) [Up to 1 year]
Diversity of treatment includes describing the types of surgical procedures and medications used to treat or manage MBO.
- Patterns of care over time in non-randomized arms, including frequency with which a patient initially selects one treatment approach is crossed over to the other strategy [Up to 1 year]
Patterns of care includes the frequency with which a patient initially selects one treatment approach and is crossed over to the other strategy.
Eligibility Criteria
Criteria
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Patient must have malignant bowel obstruction (MBO) as evidenced by all of the following:
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Clinical evidence of a bowel obstruction (via history, physical, and radiographic examination)
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Bowel obstruction below (distal to) ligament of Treitz
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Intra-abdominal primary cancer with incurable disease
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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)
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Patient must be able to tolerate a major surgical procedure based on clinical evaluation, status of their cancer, and any other underlying medical problems
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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:
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Is surgery for treatment of malignant bowel obstruction (MBO) being considered for this patient?
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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)?
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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
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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
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Patients must have Zubrod performance status of 0-2 within 7 days prior to registration
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Serum albumin must be planned to be collected after admission, but prior to treatment
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Patients must be able to complete the study questionnaires in English
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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
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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
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Cancer Center at Saint Joseph's | Phoenix | Arizona | United States | 85004 |
2 | Banner University Medical Center - Tucson | Tucson | Arizona | United States | 85719 |
3 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
4 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010 |
5 | Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
6 | Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
7 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
8 | University of Kansas Cancer Center | Kansas City | Kansas | United States | 66160 |
9 | UMass Memorial Medical Center - University Campus | Worcester | Massachusetts | United States | 01655 |
10 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109 |
11 | Essentia Health Cancer Center | Duluth | Minnesota | United States | 55805 |
12 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
13 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87102 |
14 | South Shore University Hospital | Bay Shore | New York | United States | 11706 |
15 | North Shore University Hospital | Manhasset | New York | United States | 11030 |
16 | Long Island Jewish Medical Center | New Hyde Park | New York | United States | 11040 |
17 | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | United States | 10032 |
18 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
19 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
20 | University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania | United States | 19104 |
21 | Temple University Hospital | Philadelphia | Pennsylvania | United States | 19140 |
22 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
23 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
24 | Methodist Le Bonheur Germantown Hospital | Germantown | Tennessee | United States | 38138 |
25 | The West Clinic - Wolf River | Germantown | Tennessee | United States | 38138 |
26 | Methodist Hospital | Memphis | Tennessee | United States | 38104 |
27 | University of Tennessee Health Science Center | Memphis | Tennessee | United States | 38163 |
28 | Baylor University Medical Center | Dallas | Texas | United States | 75246 |
29 | Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | United States | 77030 |
30 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
31 | University Hospital | San Antonio | Texas | United States | 78229 |
32 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78229 |
33 | Valley Health / Winchester Medical Center | Winchester | Virginia | United States | 22601 |
34 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
35 | University Health Network-Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
36 | Instituto Nacional De Cancerologia | Bogota | Colombia | 99999 | |
37 | Instituto Nacional De Cancerologia de Mexico | Mexico City | Tlalpan | Mexico | 14080 |
38 | Instituto Nacional de Enfermedades Neoplasicas | Lima | Peru | Lima 34 |
Sponsors and Collaborators
- Southwest Oncology Group
- National Cancer Institute (NCI)
- Agency for Healthcare Research and Quality (AHRQ)
Investigators
- Study Chair: Robert S Krouse, M.D., F.A.C.S., University of Arizona
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S1316
- U10CA037429
- 1R01HS021491-01A1
- S1316
- NCI-2014-01497