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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004911 |
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 |
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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 |
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 |
Study Start Date: | January 2000 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Endoscopically confirmed localized tumor as the cause of colonic obstruction
Must have symptoms of gastrointestinal obstruction, including:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
Chicago, Illinois, United States, 60611-3013 |
Study Chair: | Willis G. Parsons, MD, PC | Robert H. Lurie Cancer Center |
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 |
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 |
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 |
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 |