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Sponsors and Collaborators: |
American College of Radiology Imaging Network National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00026247 |
RATIONALE: Radiofrequency ablation may be effective in decreasing pain from bone metastases.
PURPOSE: Phase I/II trial to study the effectiveness of radiofrequency ablation in decreasing pain in patients who have bone metastases.
Condition | Intervention | Phase |
---|---|---|
Metastatic Cancer Pain Unspecified Adult Solid Tumor, Protocol Specific |
Procedure: pain therapy Procedure: radiofrequency ablation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Study of Percutaneous Radiofrequency Ablation of Bone Metastases Using CT Guidance |
Estimated Enrollment: | 75 |
Study Start Date: | November 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients undergo percutaneous CT-guided radiofrequency ablation directly to the metastatic lesion over approximately 12 minutes.
Pain and mood are assessed at baseline, daily for 14 days after treatment, and at 1 and 3 months after treatment.
Patients are followed at 1 week and then at 1 and 3 months.
PROJECTED ACCRUAL: Approximately 75 patients will be accrued for this study within 12.5 months.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Alabama | |
Comprehensive Cancer Center at University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, Massachusetts | |
UMASS Memorial Cancer Center - University Campus | |
Worcester, Massachusetts, United States, 01655 | |
United States, Missouri | |
Mallinckrodt Institute of Radiology at Washington University Medical Center | |
St. Louis, Missouri, United States, 63110 | |
United States, Ohio | |
Radiology Consultants, Incorporated | |
Youngstown, Ohio, United States, 44512 | |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | |
Philadelphia, Pennsylvania, United States, 19107-5541 | |
United States, Rhode Island | |
Comprehensive Cancer Center at Rhode Island Hospital | |
Providence, Rhode Island, United States, 02903 | |
United States, Texas | |
M.D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Damian E. Dupuy, MD | Rhode Island Hospital Comprehensive Cancer Center |
Study ID Numbers: | CDR0000069012, ACRIN-6661 |
Study First Received: | November 9, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00026247 |
Health Authority: | United States: Federal Government |
bone metastases pain unspecified adult solid tumor, protocol specific |
Neoplasm Metastasis Pain |
Neoplasms Neoplastic Processes Pathologic Processes |