Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction

• ClinicalTrials.gov Identifier: NCT00004911
• Recruitment Status: Completed
• First Posted: May 14, 2003
• Last Update Posted: June 6, 2012
• Sponsor: Northwestern University
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Northwestern University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer; Constipation, Impaction, and Bowel Obstruction; Gastric Cancer; Gastrointestinal Carcinoid Tumor; Gastrointestinal Stromal Tumor; Quality of Life; Small Intestine Cancer	Procedure: bowel obstruction management; Procedure: quality-of-life assessment	Phase 1; Phase 2

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Primary Purpose: Supportive Care
• Official Title: A Pilot Phase I/II Trial of Enteral Wallstents for Colonic Obstruction in the Setting of Malignancy
• Study Start Date: January 2000
• Actual Primary Completion Date: February 2003
• Actual Study Completion Date: February 2003

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Illinois

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, United States, 60611-3013

Sponsors and Collaborators

Northwestern University

National Cancer Institute (NCI)

Investigators

• Study Chair: Willis G. Parsons, MD, PC; Robert H. Lurie Cancer Center

More Information

• Responsible Party: Northwestern University
• ClinicalTrials.gov Identifier: NCT00004911
• Other Study ID Numbers: NU 98CC3; NU-98CC3; NCI-G00-1704
• First Posted: May 14, 2003
• Last Update Posted: June 6, 2012
• Last Verified: May 2012

Keywords provided by Northwestern University:

stage I colon cancer; stage II colon cancer; stage III colon cancer; stage IV colon cancer; stage I gastric cancer; stage II gastric cancer; stage III gastric cancer; stage IV gastric cancer; recurrent gastric cancer; stage I rectal cancer; stage II rectal cancer; stage III rectal cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; localized gastrointestinal carcinoid tumor; regional gastrointestinal carcinoid tumor; metastatic gastrointestinal carcinoid tumor; recurrent gastrointestinal carcinoid tumor; small intestine adenocarcinoma; small intestine lymphoma; small intestine leiomyosarcoma; recurrent small intestine cancer; constipation, impaction, and bowel obstruction; quality of life; gastrointestinal stromal tumor

Additional relevant MeSH terms:

Neoplasms; Stomach Neoplasms; Gastrointestinal Stromal Tumors; Carcinoid Tumor; Malignant Carcinoid Syndrome; Gastrointestinal Neoplasms; Intestinal Neoplasms; Intestinal Obstruction; Constipation; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Stomach Diseases; Signs and Symptoms, Digestive; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue