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| ID | Type | Description | Link |
|---|---|---|---|
| RITA-201-00 | |||
| MAYO-IRB-O-1223-00 | |||
| MDA-ID-01534 | |||
| RITA-IDE-G000177 |
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RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells and may help to relieve pain caused by bone metastases.
PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in relieving pain in patients who have bone metastases.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive radiofrequency ablation (RFA) to targeted tumor(s) on day 0 (multiple tumors may receive ablation in multiple sessions). Patients who achieve a reduction in worst pain of at least 2 points within 4-8 weeks but experience recurring pain at the RFA site or are diagnosed with a new painful lesion within 4-24 weeks receive 1 additional treatment to the recurring or new site.
Pain (using the Brief Pain Inventory scale of 0-10), analgesic use, and quality of life are assessed at baseline, on day 1, weekly for 4 weeks, and then every 2 weeks for 20 weeks.
Patients are followed for 6 months beyond the last RFA treatment.
PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pain therapy | Procedure | |||
| radiofrequency ablation | Procedure |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed bone metastases
Pain refractory to non-opioid analgesic medication and radiotherapy OR
Patient is considered a poor candidate for opioid analgesics or radiotherapy
Initial worst pain score within the past 24 hours at least 4 on a scale of 0-10
Tumors deemed accessible for radiofrequency ablation
No evidence of impending fracture in weight-bearing bones (more than 50% loss of cortical bone)
Tumors must be more than 1 cm from critical structures including:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| J. William Charboneau, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States | ||
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| Baltimore |
| Maryland |
| 21287 |
| United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |