ACRIN-6661: Radiofrequency Ablation in Treating Patients With Bone Metastases

• Sponsor: American College of Radiology Imaging Network (Other)
• Overall Status: Completed
• CT.gov ID: NCT00026247
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 66
• Locations: 8
• Arm: 1
• Duration (Months): 99.5
• Patients Per Site: 8.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Cancer; Pain; Unspecified Adult Solid Tumor, Protocol Specific	Procedure: pain therapy; Procedure: radiofrequency ablation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: The outcomes of the study will be adverse event analysis and pain relief.The outcomes of the study will be adverse event analysis and pain relief.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I/II Study of Percutaneous Radiofrequency Ablation of Bone Metastases Using CT Guidance
• Study Start Date: Nov 1, 2001
• Actual Primary Completion Date: Feb 15, 2010
• Actual Study Completion Date: Feb 15, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Adverse events [1 month post procedure]

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

Secondary Outcome Measures

1. Pain intensity [1 month post-procedure]

   pain intensity as measured by VASPI Scale

2. Pain intensity [3 months post-procedure]

   pain intensity as measured by VASPI Scale

3. Pain reduction [1 month post-procedure]

   pain reduction as measured by VASPR Scale

4. Pain reduction [3 month post-procedure]

   pain reduction as measured by VASPR Scale

5. Mood [1 month post-procedure]

   Mood as measured byt the VASMOOD scale

6. Mood [3 month post-procedure]

   Mood as measured by the VASMOOD scale

7. Pain Severity [1 month post-procedure]

   Pain severity as measured by the Tursky scale

8. Pain Severity [3 month post-procedure]

   Pain severity as measured by the Tursky scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Cancer Center at University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	UMASS Memorial Cancer Center - University Campus	Worcester	Massachusetts	United States	01655
3	Mallinckrodt Institute of Radiology at Washington University Medical Center	Saint Louis	Missouri	United States	63110
4	Radiology Consultants, Incorporated	Youngstown	Ohio	United States	44512
5	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104-4283
6	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania	United States	19107-5541
7	Comprehensive Cancer Center at Rhode Island Hospital	Providence	Rhode Island	United States	02903
8	M.D. Anderson Cancer Center at University of Texas	Houston	Texas	United States	77030-4009

Sponsors and Collaborators

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

Investigators

• Study Chair: Damian E. Dupuy, MD, Rhode Island Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: American College of Radiology Imaging Network
• ClinicalTrials.gov Identifier: NCT00026247
• Other Study ID Numbers: CDR0000069012; ACRIN-6661; U01CA080098; U01CA079778
• First Posted: Jan 27, 2003
• Last Update Posted: Jul 5, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Keywords provided by American College of Radiology Imaging Network: bone metastases; pain; unspecified adult solid tumor, protocol specific
• Additional relevant MeSH terms: Neoplasm Metastasis

Study Results

No Results Posted as of Jul 5, 2019