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| Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004911 |
Purpose
RATIONALE: The use of endoscopy to place a metal stent in the large intestine is less invasive than surgery for treating cancer-related bowel obstruction and may have fewer side effects and improve recovery.
PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of a metal stent in treating patients who have cancer-related bowel obstruction.
| Condition | Intervention | Phase |
|
Cancer-Related Problem/Condition Colorectal Cancer Gastric Cancer Gastrointestinal Carcinoid Tumor Gastrointestinal Stromal Tumor Small Intestine Cancer |
Procedure: bowel obstruction management Procedure: quality-of-life assessment |
Phase I Phase II |
| MedlinePlus related topics: | Cancer Carcinoid Tumors Colorectal Cancer Endoscopy Intestinal Cancer Stomach Cancer |
| Study Type: | Interventional |
| Study Design: | Supportive Care |
| Official Title: | A Pilot Phase I/II Trial of Enteral Wallstents for Colonic Obstruction in the Setting of Malignancy |
| Study Start Date: | January 2000 |
OBJECTIVES:
OUTLINE: All patient undergo a colonoscopy, followed by placement of an enteral Wallstent through an endoscope under fluoroscopic guidance into the large intestine.
Quality of life is assessed at 48 hours and 6 months after the procedure.
Patients are followed at 48 hours, 30 days, 6 months, and then yearly thereafter until death.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Endoscopically confirmed localized tumor as the cause of colonic obstruction
Must have symptoms of gastrointestinal obstruction, including:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Illinois | |||||
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |||||
| Chicago, Illinois, United States, 60611-3013 | |||||
| Robert H. Lurie Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Willis G. Parsons, MD, PC | Robert H. Lurie Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000067591, NU-98CC3, NCI-G00-1704 |
| First Received: | March 7, 2000 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004911 |
| Health Authority: | United States: Federal Government |
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