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| Sponsor: | American College of Radiology Imaging Network |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00026247 |
Purpose
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: | Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00026247 History of Changes |
| Other Study ID Numbers: | CDR0000069012, ACRIN-6661 |
| Study First Received: | November 9, 2001 |
| Last Updated: | April 7, 2011 |
| Health Authority: | United States: Federal Government |
|
bone metastases pain unspecified adult solid tumor, protocol specific |
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Bone Neoplasms Bone Marrow Diseases Neoplastic Processes |
Pathologic Processes Neoplasms by Site Bone Diseases Musculoskeletal Diseases Hematologic Diseases |