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Metastatic CancerACRIN-6661NCT00026247

Radiofrequency Ablation in Treating Patients With Bone Metastases

A study testing pain therapy and radiofrequency ablation in people with Metastatic Cancer and Pain, run by American College of Radiology Imaging Network at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 120 years
What is being tested?
pain therapy and radiofrequency ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
8 sitesUnited States
Study dates
Nov 2001to 15 Feb 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Comprehensive Cancer Center at University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • M.D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Comprehensive Cancer Center at Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Mallinckrodt Institute of Radiology at Washington University Medical Center

    St Louis, Missouri, 63110

  • UMASS Memorial Cancer Center - University Campus

    Worcester, Massachusetts, 01655

  • Radiology Consultants, Incorporated

    Youngstown, Ohio, 44512

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
pain therapy, radiofrequency ablation
Keywords
bone metastases, pain, unspecified adult solid tumor, protocol specific
Medical subject headings
Neoplasm Metastasis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pain therapyProcedure or surgery

  • radiofrequency ablationProcedure or surgery

    Also called RFA

Study groups in NCT00026247
Study groupRoleWhat they receive
RFA as pain therapyExperimentalChanges 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
Receives: Procedure: pain therapy; Procedure: radiofrequency ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

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

    Measured: 1 month post procedure

Secondary outcomes (8)

  1. Pain intensity

    pain intensity as measured by VASPI Scale

    Measured: 1 month post-procedure

  2. Pain intensity

    pain intensity as measured by VASPI Scale

    Measured: 3 months post-procedure

  3. Pain reduction

    pain reduction as measured by VASPR Scale

    Measured: 1 month post-procedure

  4. Pain reduction

    pain reduction as measured by VASPR Scale

    Measured: 3 month post-procedure

  5. Mood

    Mood as measured byt the VASMOOD scale

    Measured: 1 month post-procedure

  6. Mood

    Mood as measured by the VASMOOD scale

    Measured: 3 month post-procedure

  7. Pain Severity

    Pain severity as measured by the Tursky scale

    Measured: 1 month post-procedure

  8. Pain Severity

    Pain severity as measured by the Tursky scale

    Measured: 3 month post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startNov 2001
  3. Primary completion15 Feb 2010
  4. Study completion15 Feb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The outcomes of the study will be adverse event analysis and pain relief.
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00026247
Sponsor's protocol ID
CDR0000069012
Other IDs
ACRIN-6661, U01CA080098, U01CA079778
Acronym
ACRIN-6661
Status last verified
Jul 2019
First submitted
9 Nov 2001
Last updated
5 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All De-identified study data is available to request from ACRIN: https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx

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.

    PubMed 20041484

Questions about this trial

What is this clinical trial studying?

A study testing pain therapy and radiofrequency ablation in people with Metastatic Cancer and Pain, run by American College of Radiology Imaging Network at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: 1 month post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00026247, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.

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