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
  Purpose

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.


Condition Intervention Phase
Metastatic Cancer
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: pain therapy
Procedure: radiofrequency ablation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Percutaneous Radiofrequency Ablation of Bone Metastases Using CT Guidance

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Adverse events [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 75
Study Start Date: November 2001
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00026247

Locations
United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Massachusetts
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Missouri
Mallinckrodt Institute of Radiology at Washington University Medical Center
St. Louis, Missouri, United States, 63110
United States, Ohio
Radiology Consultants, Incorporated
Youngstown, Ohio, United States, 44512
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
United States, Rhode Island
Comprehensive Cancer Center at Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
American College of Radiology Imaging Network
Investigators
Study Chair: Damian E. Dupuy, MD Rhode Island Hospital
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00026247     History of Changes
Other Study ID Numbers: CDR0000069012, ACRIN-6661
Study First Received: November 9, 2001
Last Updated: April 7, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
bone metastases
pain
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014