Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Radiofrequency Ablation in Treating Patients With Bone Metastases

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Supportive care, Treatment	Closed	21 and over	NCI	ACRIN-6661 NCT00026247

Objectives

1. Determine the side effects of radiofrequency ablation in patients with bone metastases.
2. Determine the effect of this regimen on pain in these patients.
3. Determine the effect of this regimen on mood in these patients.
4. Determine the effects of narcotic usage in patients treated with this regimen.
5. Determine the relationship between laboratory and imaging features of this treatment and the effects of the treatment in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed malignant disease with a bone lesion that appears to be metastatic disease by clinical and/or imaging techniques
• Persistent intractable pain from a solitary site of bone metastases (greater than 5 on pain scale of 0-10)
• Bone metastasis must be amenable to radiofrequency ablation using a percutaneous CT-guided approach
• Bone metastasis must be no greater than 8 cm
• No tumor mass in contact with hollow viscera
• No primary musculoskeletal malignancies, lymphoma, or leukemia
• No spinal metastases that do not have an intact cortex between the mass and the spinal canal and exiting nerve roots
• No tumor involving weight-bearing long bone of lower extremity or impending fracture

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 14 days since prior chemotherapy for metastatic disease
• No concurrent systemic chemotherapy for metastatic disease during and for 14 days after study therapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 30 days since prior radioisotopes for metastatic disease
• No concurrent systemic radioisotopes for metastatic disease

Surgery:

• No surgical stabilization of tumor site with metallic hardware

Other:

• Prior aspirin, nonsteroidal anti-inflammatory medications, antiplatelet medications, or warfarin must be discontinued for an appropriate period of time prior to study based on the drug's half-life and known antiplatelet activity (e.g., 7 days for aspirin and 24 hours for ibuprofen)
• At least 24 hours since prior low molecular weight heparin

Patient Characteristics:

Age:

• 21 and over

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Platelet count at least 70,000/mm³
• No uncontrolled coagulopathy or bleeding diathesis that cannot be corrected with fresh frozen plasma and platelets

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

• No pacemaker

Expected Enrollment

Approximately 75 patients will be accrued for this study within 12.5 months.

Outcomes

Adverse events

Pain intensity as assessed by the Memorial Pain Assessment Cards
Pain relief
Pain severity
Mood

Outline

This is a multicenter study.

Patients undergo percutaneous CT-guided radiofrequency ablation directly to the metastatic lesion over approximately 12 minutes.

Pain and mood are assessed at baseline, daily for 14 days after treatment, and at 1 and 3 months after treatment.

Patients are followed at 1 week and then at 1 and 3 months.

Trial Contact Information

Trial Lead Organizations

American College of Radiology Imaging Network

Damian Dupuy, MD, Protocol chair		Ph: 401-444-5184

Registry Information
Official Title		A Phase I/II Study of Percutaneous Radiofrequency Ablation of Bone Metastases using CT Guidance
Trial Start Date		2001-11-01
Registered in ClinicalTrials.gov		NCT00026247
Date Submitted to PDQ		2001-09-07
Information Last Verified		2006-03-31
NCI Grant/Contract Number		CA080098

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