Radiofrequency Ablation in Treating Patients With Bone Metastases

NCT00026247 | Completed DMC

• 4 other identifiers: CDR0000069012ACRIN-6661U01CA080098U01CA079778
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 8

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.

Conditions

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

Keywords

bone metastases; pain; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Estimate the adverse event rate due to RFA within 1 month follow-up period.

  1 month post procedure

Secondary Outcomes (8)

• Pain intensity

  1 month post-procedure

• Pain intensity

  3 months post-procedure

• Pain reduction

  1 month post-procedure

• Pain reduction

  3 month post-procedure

• Mood

  1 month post-procedure

Study Arms (1)

RFA as pain therapy

EXPERIMENTAL

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

Interventions

pain therapy PROCEDURE

RFA as pain therapy

radiofrequency ablation PROCEDURE

Also known as: RFA

RFA as pain therapy

Eligibility Criteria

• Age: 21 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically documented malignant disease with a bone lesion that has the clinical and/imaging features of metastatic disease.
• 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)).
• 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.
• Radiofrequency treatment can be performed within 5 days of baseline evaluations.
• All patients must understand and sign a study-specific informed consent.

You may not qualify if:

• 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.
• 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).
• Patients with primary musculoskeletal malignancies, lymphoma and leukemia will not be RFA treatment candidates.
• Spinal metastases that do not have an intact cortex between the mass and the spinal canal and exiting nerve roots.
• Patients with a pacemaker.

Sponsors & Collaborators

• American College of Radiology Imaging Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (8)

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

UMASS Memorial Cancer Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

Mallinckrodt Institute of Radiology at Washington University Medical Center

St Louis, Missouri, 63110, United States

Location

Radiology Consultants, Incorporated

Youngstown, Ohio, 44512, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Comprehensive Cancer Center at Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Related Publications (1)

• 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.

  PMID: 20041484 RESULT

MeSH Terms

Conditions

Neoplasm Metastasis; Pain

Interventions

Analgesia; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Damian E. Dupuy, MD

  Rhode Island Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: The outcomes of the study will be adverse event analysis and pain relief.

Study Record Dates

• First Submitted: November 9, 2001
• First Posted: January 27, 2003
• Study Start: November 1, 2001
• Primary Completion: February 15, 2010
• Study Completion: February 15, 2010
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share

Locations

US (8)