Colon Cancer Clinical Trial
Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction
Summary
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.
Full Description
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.
Eligibility 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
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There is 1 Location for this study
Chicago Illinois, 60611, United States
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