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Home > "R" Clinical Trials Conditions > Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases  Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases
Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases
For Condition: Pain,bone metastases
Status: No longer recruiting
Sponsor(s): RITA Medical Systems ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
J.Charboneau, Study Chair, Mayo Clinic Cancer Center
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
United States
Additional Information:
Study ID Numbers: CDR0000069180; RITA-IDE-G000177,RITA-201-00,MAYO-IRB-O-1223-00,MDA-ID-01534
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00029029
Other Bone Metastases Studies:
1. Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer
2. Radiofrequency Ablation in Treating Patients With Bone Metastases
3. Lidocaine Patch in Treating Cancer Patients with Neuropathic Pain After Surgery
4. Light-Emitting Diode Therapy in Preventing Mucositis in Children Receiving Chemotherapy With or Without Radiation Therapy Before Bone Marrow Transplantation
5. Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy
Related Studies:
Other bone metastases Clinical Trials
Other Wisconsin Clinical Trials
Other Milwaukee Clinical Trials
Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases
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