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.

View Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Colon Cancer

Phase:

Phase 1

Study ID:

NCT00004911

Recruitment Status:

Completed

Sponsor:

Northwestern University

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago Illinois, 60611, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 1

Study ID:

NCT00004911

Recruitment Status:

Completed

Sponsor:


Northwestern University

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider