Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases



Status:Active, not recruiting
Conditions:Cancer, Cancer, Chronic Pain
Therapuetic Areas:Musculoskeletal, Oncology
Healthy:No
Age Range:18 - 120
Updated:6/8/2018
Start Date:October 13, 2000
End Date:October 24, 2020

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RF Ablation of Painful Metastases Involving Bone

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:

- 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.

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
We found this trial at
6
sites
55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Massachusetts General Hospital Cancer Center An integral part of one of the world
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Boston, MA
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Baltimore, Maryland 21231
410-955-6190
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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Baltimore, MD
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Chicago, IL
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Milwaukee, Wisconsin 53215
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Milwaukee, WI
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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Rochester, MN
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