Expired Study
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Chicago, Illinois 60611


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.


Study summary:

OBJECTIVES: - Determine the objective response and clinical outcome in patients with colonic obstruction secondary to malignancy treated with enteral Wallstents. - Evaluate the efficacy and safety of this treatment in these patients. - Evaluate the quality of life of these patients after enteral Wallstent placement. 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.


Criteria:

DISEASE CHARACTERISTICS: - Endoscopically confirmed localized tumor as the cause of colonic obstruction - All primary tumor types are eligible - No prior colonic Wallstents - Must have symptoms of gastrointestinal obstruction, including: - Inability to move bowels, absence of flatus, nausea/vomiting, abdominal pain, or diarrhea PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-3 Life expectancy: - Not specified Hematopoietic: - Platelet count greater than 50,000/mm^3 Hepatic: - INR no greater than 1.5 times upper limit of normal Renal: - Not specified Cardiovascular: - No cardiac condition Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No significant active infection (e.g., pneumonia, peritonitis, wound abscess) that would preclude endoscopy - No other serious concurrent illness - No uncontrolled metabolic disease (e.g., diabetes or hypothyroidism) - No dementia, psychiatric disorder, or altered mental status that would preclude compliance - History of other neoplastic disease allowed - Veterans Administration patients are not eligible PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Prior or concurrent chemotherapy allowed Endocrine therapy: - Not specified Radiotherapy: - Prior or concurrent radiotherapy allowed Surgery: - At least 3 weeks since prior surgery and recovered


NCT ID:

NCT00004911


Primary Contact:

Study Chair
Willis G. Parsons, MD, PC
Robert H. Lurie Cancer Center


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60611
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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