RF Ablation of Painful Metastases Involving Bone
18 Years
N/A
Both
Metastatic Cancer, Pain
Trial Information
RF Ablation of Painful Metastases Involving Bone
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Supportive Care
Principal Investigator
J. William Charboneau, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000069180
NCT ID:
NCT00029029
Start Date:
October 2000
Completion Date:
Related Keywords:
- Metastatic Cancer
- Pain
- bone metastases
- pain
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| St. Luke's Medical Center | Milwaukee, Wisconsin 53215 |
| Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
| Northwestern Memorial Hospital | Chicago, Illinois 60611 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
