Radiofrequency Ablation in Treating Patients With Bone Metastases

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00026247
First received: November 9, 2001
Last updated: April 7, 2011
Last verified: March 2006

November 9, 2001
April 7, 2011
November 2001
February 2011   (final data collection date for primary outcome measure)
Adverse events [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00026247 on ClinicalTrials.gov Archive Site
  • Pain intensity as assessed by the Memorial Pain Assessment Cards [ Designated as safety issue: No ]
  • Pain relief [ Designated as safety issue: No ]
  • Pain severity [ Designated as safety issue: No ]
  • Mood [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Radiofrequency Ablation in Treating Patients With Bone Metastases
A Phase I/II Study of Percutaneous Radiofrequency Ablation of Bone Metastases Using CT Guidance

RATIONALE: Radiofrequency ablation may be effective in decreasing pain from bone metastases.

PURPOSE: Phase I/II trial to study the effectiveness of radiofrequency ablation in decreasing pain in patients who have bone metastases.

OBJECTIVES:

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

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.

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

Interventional
Phase 1
Phase 2
Masking: Open Label
Primary Purpose: Treatment
  • Metastatic Cancer
  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Procedure: pain therapy
  • Procedure: radiofrequency ablation
Not Provided
Dupuy DE, Liu D, Hartfeil D, Hanna L, Blume JD, Ahrar K, Lopez R, Safran H, DiPetrillo T. Percutaneous radiofrequency ablation of painful osseous metastases: a multicenter American College of Radiology Imaging Network trial. Cancer. 2010 Feb 15;116(4):989-97. doi: 10.1002/cncr.24837.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
Not Provided
February 2011   (final data collection date for primary outcome measure)

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

PATIENT CHARACTERISTICS:

Age:

  • 21 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Platelet count at least 70,000/mm^3
  • 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

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00026247
CDR0000069012, ACRIN-6661
Not Provided
Not Provided
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Study Chair: Damian E. Dupuy, MD Rhode Island Hospital
National Cancer Institute (NCI)
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP