Radiofrequency Ablation in Treating Patients With Bone Metastases

NCT ID: NCT00026247

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-30
• Study Completion Date: 2010-02-15

Brief Summary

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.

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.

Conditions

Metastatic Cancer; Pain; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RFA as pain therapy

Changes in the severity of pain as measured using using the Memorial Pain Assessment Cards (MPAC) before and after RadioFrequency Ablation (RFA) will be statistically analyzed

Group Type: EXPERIMENTAL

pain therapy

Intervention Type: PROCEDURE

radiofrequency ablation

Intervention Type: PROCEDURE

Interventions

pain therapy

Intervention Type: PROCEDURE

radiofrequency ablation

Intervention Type: PROCEDURE

Other Intervention Names

RFA

Eligibility Criteria

Inclusion Criteria

4.1.1 Histologically or cytologically documented malignant disease with a bone lesion that has the clinical and/imaging features of metastatic disease.

4.1.2 Persistent intractable pain that results in a return visit to the oncologist. The measurable pain must be above a pain scale of five (scale of 0-10). (Pain during the last week described as "the worst" by the patient on a scale of 0 (no pain) to 10 (pain as bad as patient can imagine)).

4.1.3 The patient's pain must be from a solitary site of metastatic disease in the bone. Each site must be amenable to RFA utilizing a percutaneous CT-guided approach. (RF electrode can be safely placed under CT guidance without harm to normal structures.) 4.1.4 The maximum size of the bone metastasis (study site) must be no greater than 8 cm.

4.1.5 Radiofrequency treatment can be performed within 5 days of baseline evaluations.

4.1.6 All patients must understand and sign a study-specific informed consent.

Exclusion Criteria

4.2.1 Tumor mass in contact with hollow viscera. 4.2.2 Uncontrolled coagulopathy or bleeding diathesis that cannot be corrected with FFP and platelets prior to procedure. (Platelets must be ≥ 70,000/ul.) 4.2.3 Aspirin and nonsteroidal anti-inflammatory medications, antiplatelet medications, or warfarin must be discontinued prior to the procedure for a time period that is appropriate given the drug half life and the drugs known antiplatelet activity (e.g. aspirin for 7 days and ibuprofen 24 hours). Low molecular weight heparin preparations must be discontinued 24 hours prior to procedure.

4.2.4 Tumor involves a weight-bearing long-bone of the lower extremity. 4.2.5 Site of tumor surgically stabilized with metallic hardware. 4.2.6 Previous (within 30 days immediately prior to RFA or post RFA) or scheduled concurrent systemic treatment of metastases with external beam radiation or radioisotopes. (Chemotherapy will not be allowed within 14 days prior to and within 14 days post RFA procedure).

4.2.7 Patients with primary musculoskeletal malignancies, lymphoma and leukemia will not be RFA treatment candidates.

4.2.8 Spinal metastases that do not have an intact cortex between the mass and the spinal canal and exiting nerve roots.

4.2.8 Patients with a pacemaker.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

American College of Radiology Imaging Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Damian E. Dupuy, MD

Role: STUDY_CHAIR

Rhode Island Hospital

Locations

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, United States

UMASS Memorial Cancer Center - University Campus

Worcester, Massachusetts, United States

Mallinckrodt Institute of Radiology at Washington University Medical Center

St Louis, Missouri, United States

Radiology Consultants, Incorporated

Youngstown, Ohio, United States

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, United States

Comprehensive Cancer Center at Rhode Island Hospital

Providence, Rhode Island, United States

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20041484 (View on PubMed)

Other Identifiers

ACRIN-6661

Identifier Type: OTHER

Identifier Source: secondary_id

U01CA080098

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01CA079778

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000069012

Identifier Type: -

Identifier Source: org_study_id