Clinical trial NCT00029029: Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases
Official title: RF Ablation of Painful Metastases Involving Bone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Cancer
Pain
Keywords: bone metastases
pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: J. William Charboneau, MD
role: STUDY_CHAIR
References: