Radiofrequency Ablation in Treating Patients With Bone Metastases (ACRIN-6661)

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.

Study Overview

• Status: Completed
• Conditions: Pain; Unspecified Adult Solid Tumor, Protocol Specific; Metastatic Cancer
• Intervention / Treatment: Procedure: pain therapy; Procedure: radiofrequency ablation

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Comprehensive Cancer Center at University of Alabama at Birmingham
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMASS Memorial Cancer Center - University Campus
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Mallinckrodt Institute of Radiology at Washington University Medical Center
  • Ohio
    • Youngstown, Ohio, United States, 44512
      • Radiology Consultants, Incorporated
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-4283
      • Abramson Cancer Center of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107-5541
      • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Comprehensive Cancer Center at Rhode Island Hospital
  • Texas
    • Houston, Texas, United States, 77030-4009
      • M.D. Anderson Cancer Center at University of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 120 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

4.1 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.

4.2 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Procedure: pain therapy; Procedure: radiofrequency ablation; Other Names: RFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Estimate the adverse event rate due to RFA within 1 month follow-up period.	1 month post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	pain intensity as measured by VASPI Scale	1 month post-procedure
Pain intensity	pain intensity as measured by VASPI Scale	3 months post-procedure
Pain reduction	pain reduction as measured by VASPR Scale	1 month post-procedure
Pain reduction	pain reduction as measured by VASPR Scale	3 month post-procedure
Mood	Mood as measured byt the VASMOOD scale	1 month post-procedure
Mood	Mood as measured by the VASMOOD scale	3 month post-procedure
Pain Severity	Pain severity as measured by the Tursky scale	1 month post-procedure
Pain Severity	Pain severity as measured by the Tursky scale	3 month post-procedure

Collaborators and Investigators

• Sponsor: American College of Radiology Imaging Network
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2001
• Primary Completion (ACTUAL): February 15, 2010
• Study Completion (ACTUAL): February 15, 2010

Study Registration Dates

• First Submitted: November 9, 2001
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (ESTIMATE): January 27, 2003

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: unspecified adult solid tumor, protocol specific; pain; bone metastases
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: CDR0000069012; U01CA080098 (U.S. NIH Grant/Contract); U01CA079778 (U.S. NIH Grant/Contract); ACRIN-6661 (OTHER: CIP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

All De-identified study data is available to request from ACRIN:

https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No