Back to resultsRadiofrequency Ablation in Relieving Pain in Patients With Bones Metastases
Primary Purpose
Metastatic Cancer, Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pain therapy
radiofrequency ablation
Sponsored by
About this trial
This is an interventional supportive care trial for Metastatic Cancer focused on measuring bone metastases, pain
Eligibility 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
Sites / Locations
- Northwestern Memorial Hospital
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Massachusetts General Hospital Cancer Center
- Mayo Clinic Cancer Center
- University of Texas - MD Anderson Cancer Center
- St. Luke's Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00029029
Brief Title
Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases
Official Title
RF Ablation of Painful Metastases Involving Bone
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 13, 2000 (Actual)
Primary Completion Date
October 24, 2002 (Actual)
Study Completion Date
October 24, 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer, Pain
Keywords
bone metastases, pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
pain therapy
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. William Charboneau, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases
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