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

SWOG Cancer Research Network

Status: Completed

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

Treatments: Other: quality-of-life assessment; Procedure: therapeutic conventional surgery; Procedure: gastrointestinal complications management/prevention

Study type: Interventional

Funder types: NETWORK; Other U.S. Federal agency; NIH

Identifiers

NCT02270450

1R01HS021491-01A1 (U.S. AHRQ Grant/Contract)

NCI-2014-01497 (Other Identifier)

S1316 (Other Identifier)

U10CA037429 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 221 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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221 participants in 4 patient groups

Arm I (randomized to surgery)

Experimental group

Description:

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

Treatment:

Procedure: therapeutic conventional surgery

Other: quality-of-life assessment

Arm II (randomized to non-surgical management)

Experimental group

Description:

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

Treatment:

Procedure: gastrointestinal complications management/prevention

Other: quality-of-life assessment

Arm III (no randomization, surgery)

Experimental group

Description:

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

Treatment:

Procedure: therapeutic conventional surgery

Other: quality-of-life assessment

Arm IV (no randomization, non-surgical management)

Experimental group

Description:

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

Treatment:

Procedure: gastrointestinal complications management/prevention

Other: quality-of-life assessment