Clinical Trial 19100

Cancer Type: Gastrointestinal Tumor
Interventions:Not Applicable

Study Type: Treatment
Phase of Study: Phase IV
Investigators:

  • Jose Pimiento

Overview

Study Title

Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction

Summary

The purpose of this study is to enroll two groups of study participants to compare the quality of life of patients with Malignant Bowel Obstruction (MBO) who are treated with surgery to that of similar patients who are treated with the best medical management (non-surgical treatment).

Objective

1.1 Primary Objective To compare quality of life, as assessed by the number of days alive and outside of the hospital within the first 91 days (13 weeks) after registration, among patients with malignant bowel obstruction (MBO) who receive surgical intervention and similar patients treated non-surgically. 1.2 Other Objectives a. To explore whether there are differences in other health related quality of life (HRQOL) factors of particular interest in this population, including ability to eat, days with nasogastric tube, development of nausea, days of intravenous hydration, days eating solid foods and days drinking that are different for patients with MBO who receive surgical intervention as compared to non-surgical intervention. b. To explore whether overall survival is different for patients with MBO who receive surgical intervention as compared to non-surgical intervention. c. To estimate the effects of surgical versus non-surgical management on quality of life after adjustment for non-adherence to initially assigned/chosen treatment. d. To explore whether there are clinical factors (e.g., ascites, albumin, carcinomatosis) that predict better quality of life outcomes for patients with malignant bowel obstruction who receive surgical intervention as compared to non-surgical intervention.

Inclusion Criteria

  • Participants 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.
  • 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).
  • 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)?
  • 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.
  • 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.
  • 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.
  • Additional criteria may apply.

  • Exclusion Criteria

  • 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.