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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00004911
Other study ID # NU 98CC3
Secondary ID NU-98CC3NCI-G00-
Status Completed
Phase Phase 1/Phase 2
First received March 7, 2000
Last updated May 31, 2012
Start date January 2000
Est. completion date February 2003

Study information

Verified date May 2012
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date February 2003
Est. primary completion date February 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Primary Purpose: Supportive Care


Intervention

Procedure:
bowel obstruction management

quality-of-life assessment


Locations

Country Name City State
United States Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Northwestern University National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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