Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Cancer Pain |
Procedure: pain therapy Procedure: radiofrequency ablation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Supportive Care |
| Official Title: | RF Ablation of Painful Metastases Involving Bone |
| Study Start Date: | October 2000 |
OBJECTIVES:
- Determine the efficacy of radiofrequency ablation, in terms of pain relief at 4 weeks, in patients with painful bone metastases.
- Determine the safety of this regimen in these patients.
- Compare the change in pain interference with daily life and analgesic use at 4 weeks vs baseline in patients treated with this regimen.
- Determine the time to recurrence of worst pain in patients treated with this regimen.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
- Spinal cord, brain, or other critical nerve structures
- Large abdominal vessel (e.g., aorta or inferior vena cava)
- Bowel or bladder
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Not specified
Life expectancy:
- More than 2 months
Hematopoietic:
- Platelet count at least 75,000/mm3
Hepatic:
- INR less than 1.5
Renal:
- Not specified
Other:
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 3 weeks since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 3 weeks since prior radiotherapy
Surgery:
- Not specified
Other:
- At least 3 days since prior aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs
- No concurrent anticoagulants
Contacts and Locations| United States, Illinois | |
| Northwestern Memorial Hospital | |
| Chicago, Illinois, United States, 60611 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| United States, Wisconsin | |
| St. Luke's Medical Center | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Study Chair: | J. William Charboneau, MD | Mayo Clinic |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00029029 History of Changes |
| Other Study ID Numbers: | CDR0000069180, RITA-201-00, MAYO-IRB-O-1223-00, MDA-ID-01534, RITA-IDE-G000177 |
| Study First Received: | January 4, 2002 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
bone metastases pain |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013