Metastatic CancerPhase 2NCT00029029
Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases
A Phase 2 study testing pain therapy and radiofrequency ablation in people with Metastatic Cancer and Pain, run by Mayo Clinic at 6 sites in United States.
Trial summary
RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells and may help to relieve pain caused by bone metastases. PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in relieving pain in patients who have bone metastases. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Metastatic Cancer, Pain
- What is being tested?
- pain therapy and radiofrequency ablation
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 6 sitesUnited States
- Study dates
- 13 Oct 2000to 24 Oct 2002
- Phase
- Phase 2
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed bone metastases
- Pain refractory to non-opioid analgesic medication and radiotherapy OR
- Patient is considered a poor candidate for opioid analgesics or radiotherapy
- Initial worst pain score within the past 24 hours at least 4 on a scale of 0-10
- Tumors deemed accessible for radiofrequency ablation
- No evidence of impending fracture in weight-bearing bones (more than 50% loss of cortical bone)
- Tumors must be more than 1 cm from critical structures including:
- Spinal cord, brain, or other critical nerve structures
- Large abdominal vessel (e.g., aorta or inferior vena cava)
- Bowel or bladder
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Not specified
Life expectancy:
- More than 2 months
Hematopoietic:
- Platelet count at least 75,000/mm3
Hepatic:
- INR less than 1.5
Renal:
- Not specified
Other:
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 3 weeks since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 3 weeks since prior radiotherapy
Surgery:
- Not specified
Other:
- At least 3 days since prior aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs
- No concurrent anticoagulants
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
About this study
Official title: RF Ablation of Painful Metastases Involving Bone
RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells and may help to relieve pain caused by bone metastases.
PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in relieving pain in patients who have bone metastases.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of radiofrequency ablation, in terms of pain relief at 4 weeks, in patients with painful bone metastases.
- Determine the safety of this regimen in these patients.
- Compare the change in pain interference with daily life and analgesic use at 4 weeks vs baseline in patients treated with this regimen.
- Determine the time to recurrence of worst pain in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive radiofrequency ablation (RFA) to targeted tumor(s) on day 0 (multiple tumors may receive ablation in multiple sessions). Patients who achieve a reduction in worst pain of at least 2 points within 4-8 weeks but experience recurring pain at the RFA site or are diagnosed with a new painful lesion within 4-24 weeks receive 1 additional treatment to the recurring or new site.
Pain (using the Brief Pain Inventory scale of 0-10), analgesic use, and quality of life are assessed at baseline, on day 1, weekly for 4 weeks, and then every 2 weeks for 20 weeks.
Patients are followed for 6 months beyond the last RFA treatment.
PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.
- Conditions
- Metastatic Cancer, Pain
- Being tested
- pain therapy, radiofrequency ablation
- Keywords
- bone metastases, pain
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start13 Oct 2000
- Primary completion24 Oct 2002
- Study completion24 Oct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Supportive care
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J. William Charboneau, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029029
- Sponsor's protocol ID
- CDR0000069180
- Other IDs
- RITA-201-00, MAYO-IRB-O-1223-00, MDA-ID-01534, RITA-IDE-G000177
- Status last verified
- Aug 2020
- First submitted
- 4 Jan 2002
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RF Ablation of Painful Metastases Involving Bone
- ClinicalTrials.gov ID
- NCT00029029
- Acronym / sponsor ID
- CDR0000069180
- Conditions
- Metastatic Cancer, Pain
- Keywords
- bone metastases, pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 13 Oct 2000 (actual)
- Primary completion
- 24 Oct 2002 (actual)
- Study completion
- 24 Oct 2002 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells and may help to relieve pain caused by bone metastases.
PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in relieving pain in patients who have bone metastases.
Detailed description
OBJECTIVES:
- Determine the efficacy of radiofrequency ablation, in terms of pain relief at 4 weeks, in patients with painful bone metastases.
- Determine the safety of this regimen in these patients.
- Compare the change in pain interference with daily life and analgesic use at 4 weeks vs baseline in patients treated with this regimen.
- Determine the time to recurrence of worst pain in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive radiofrequency ablation (RFA) to targeted tumor(s) on day 0 (multiple tumors may receive ablation in multiple sessions). Patients who achieve a reduction in worst pain of at least 2 points within 4-8 weeks but experience recurring pain at the RFA site or are diagnosed with a new painful lesion within 4-24 weeks receive 1 additional treatment to the recurring or new site.
Pain (using the Brief Pain Inventory scale of 0-10), analgesic use, and quality of life are assessed at baseline, on day 1, weekly for 4 weeks, and then every 2 weeks for 20 weeks.
Patients are followed for 6 months beyond the last RFA treatment.
PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pain therapy | Procedure or surgery | – |
| radiofrequency ablation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. William Charboneau, MD study chair
Mayo Clinic
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pain therapy and radiofrequency ablation in people with Metastatic Cancer and Pain, run by Mayo Clinic at 6 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 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
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 12 Aug 2020.