Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Supportive care	Closed	18 and over	NCI	NU-98CC2 NCI-G00-1703, NCT00004910

Objectives

1. Determine the objective response and clinical outcome in patients with duodenal obstruction secondary to malignancy treated with enteral Wallstents.
2. Evaluate the efficacy and safety of this treatment in these patients.
3. Evaluate the quality of life of these patients after enteral Wallstent placement.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-3

Life expectancy:

• Not specified

Hematopoietic:

• Platelet count greater than 50,000/mm³

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

Expected Enrollment

A total of 20 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Willis Parsons, MD, PC, Protocol chair		Ph: 312-943-3727 Email: willisparsons@comcast.net

Registry Information
Official Title		A Pilot Phase I/II Trial of Enteral Wallstents for Duodenal Obstruction in the Setting of Malignancy
Trial Start Date		2000-01-05
Registered in ClinicalTrials.gov		NCT00004910
Date Submitted to PDQ		2000-01-13
Information Last Verified		2000-05-08
NCI Grant/Contract Number		P30-CA60553

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