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Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction
This study is ongoing, but not recruiting participants.
First Received: March 7, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004911
  Purpose

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 Intervention Phase
Cancer-Related Problem/Condition
Colorectal Cancer
Gastric Cancer
Gastrointestinal Carcinoid Tumor
Gastrointestinal Stromal Tumor
Small Intestine Cancer
Procedure: bowel obstruction management
Procedure: quality-of-life assessment
Phase I
Phase II

MedlinePlus related topics: Cancer Carcinoid Tumors Colorectal Cancer Endoscopy Intestinal Cancer Stomach Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care
Official Title: A Pilot Phase I/II Trial of Enteral Wallstents for Colonic Obstruction in the Setting of Malignancy

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004911

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Robert H. Lurie Cancer Center
Investigators
Study Chair: Willis G. Parsons, MD, PC Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067591, NU-98CC3, NCI-G00-1704
Study First Received: March 7, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004911     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Gastrointestinal Diseases
Leiomyosarcoma
Rectal Neoplasms
Colonic Diseases
Quality of Life
Ileal Diseases
Rectal Diseases
Duodenal Neoplasms
Intestinal Obstruction
Stomach Diseases
Ileal Neoplasms
Stomach Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Lymphoma
Duodenal Diseases
Carcinoid Syndrome
Jejunal Neoplasms
Digestive System Neoplasms
Rectal Neoplasm
Serotonin Syndrome
Malignant Carcinoid Syndrome
Intestinal Diseases
Recurrence
Intestinal Neoplasms
Neuroendocrine Tumors
Carcinoma
Neuroectodermal Tumors
Rectal Cancer
Digestive System Diseases

Additional relevant MeSH terms:
Gastrointestinal Diseases
Neoplasms, Nerve Tissue
Colonic Diseases
Ileal Diseases
Rectal Diseases
Duodenal Neoplasms
Intestinal Obstruction
Stomach Diseases
Neoplasms by Site
Ileal Neoplasms
Jejunal Diseases
Stomach Neoplasms
Neoplasms, Germ Cell and Embryonal
Duodenal Diseases
Jejunal Neoplasms
Neoplasms by Histologic Type
Digestive System Neoplasms
Malignant Carcinoid Syndrome
Intestinal Diseases
Intestinal Neoplasms
Neuroendocrine Tumors
Carcinoma
Neuroectodermal Tumors
Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Carcinoid Tumor
Gastrointestinal Stromal Tumors
Adenocarcinoma
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009