Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: The use of endoscopy to place metal stents in the duodenum is less invasive than surgery for treating cancer-related duodenal obstruction and may have fewer side effects and improve recovery.

PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of metal stents in treating patients who have cancer-related obstruction of the duodenum.

Further Study Information

OBJECTIVES:

• Determine the objective response and clinical outcome in patients with duodenal 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: Patients undergo enteral Wallstent placement through an endoscope under fluoroscopic guidance into the duodenum.

Quality of life is assessed at 48 hours and 6 months after 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 duodenal obstruction

• All primary tumor types are eligible

• No prior duodenal 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, or wound abscess) that would preclude endoscopy

• No other serious concurrent illness

• No uncontrolled metabolic disease (e.g., diabetes mellitus 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Willis G. Parsons

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00004910
Information obtained from ClinicalTrials.gov on December 14, 2011

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