Multi-metastatic CancerPERFACOOLNCT03738670
Bipolar RFA of Painful Extra-spinal Bone Metastases
A study testing Percutaneous RFA in people with Multi-metastatic Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
To evaluate the worst pain of cancer patients with painful extra-spinal bone metastases 1 month after bipolar radiofrequency ablation (RFA) performed with the Osteocool system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multi-metastatic Cancer
- What is being tested?
- Percutaneous RFA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2019to 6 Oct 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Multi-metastatic cancer patients with at least one painful lytic bone metastasis
- 2) Target lesion should correspond to a specific radiologic finding
- 3) At least a moderate pain produce by target lesion (4 on a scale of 0 to 10 over the prior 24 hours with or without pain killers intake) assessed during selection evaluation
- 4) Patients 18 years old
- 5) Able to give written consent
- 6) Life expectancy 1 months
- 7) Patient affiliated to the National Health Insurance system
Who cannot join
- Radiation therapy on the target tumor terminated < 3 weeks before treatment
- Any contra-indication for the procedure as stated by the radiologist in terms of tumor size, proximity to neural/vascular structures making the procedure at unacceptable risk
- Any contra-indication for the procedure as stated by the radiologist related to patient's condition (e.g. cardiac pacemakers) making the procedure at unacceptable risk
- Impaired haemostasis
- Concurrent participation in other experimental studies that could affect endpoints of this study
- Contraindication to any form of sedation/anaesthesia
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- Signs of local/systemic infection identified before procedure, in accordance with standard care
- Sclerotic metastases
- Adults under guardianship
- Patients under judicial protection
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Evaluation After Treatment of Extra-spinal Bone Metastases With OsteoCOOL Radiofrequency (RF) Ablation System
To evaluate the worst pain of cancer patients with painful extra-spinal bone metastases 1 month after bipolar radiofrequency ablation (RFA) performed with the Osteocool system.
- Conditions
- Multi-metastatic Cancer
- Being tested
- Percutaneous RFA
- Keywords
- Pain, Extra-spinal, RFA, Radiofrequency ablation, Bone metastases
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous RFAProcedure or surgery
Single session percutaneous extra-spinal bone metastasis destruction to achieve pain relief
| Study group | Role | What they receive |
|---|---|---|
| RFA | Experimental | Single-arm prospective observational study Receives: Procedure: Percutaneous RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of responding patients reporting an improvement of at least 3 points on item 3 "the worst pain in the last 24 hours" of Brief Pain Inventory (BPI) questionnaire
Measured: 1 month
Secondary outcomes (4)
Comparison of the mean scores of the items 3, 5, 9B and 8 of the BPI questionnaire between the baseline and 6-month follow-up
Measured: 6 months
Safety will be assessed according to SIR(11) / CTCAE classification
Measured: 6 months
Mean scores variation of the morphine milligram equivalents (MME) (based on patient consumption diary) between the baseline and 6-month follow-up.
Measured: 6 months
Percentage of responding patients defined by an improvement of at least 3 points on item 3 "the worst pain in the last 24 hours" of Brief Pain Inventory (BPI) questionnaire at 3 and 6 month follow-up.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start12 Jun 2019
- Primary completion2 Dec 2021
- Study completion6 Oct 2023
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi-metastatic CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luigi Roberto CAZZATO, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738670
- Sponsor's protocol ID
- 7010
- Acronym
- PERFACOOL
- Status last verified
- Aug 2024
- First submitted
- 5 Nov 2018
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Evaluation After Treatment of Extra-spinal Bone Metastases With OsteoCOOL Radiofrequency (RF) Ablation System
- ClinicalTrials.gov ID
- NCT03738670
- Acronym / sponsor ID
- PERFACOOL / 7010
- Conditions
- Multi-metastatic Cancer
- Keywords
- Pain, Extra-spinal, RFA, Radiofrequency ablation, Bone metastases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 13 Nov 2018 (actual)
- 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.
To evaluate the worst pain of cancer patients with painful extra-spinal bone metastases 1 month after bipolar radiofrequency ablation (RFA) performed with the Osteocool system.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RFA | Experimental | Procedure: Percutaneous RFASingle-arm prospective observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1) Multi-metastatic cancer patients with at least one painful lytic bone metastasis
- 2) Target lesion should correspond to a specific radiologic finding
- 3) At least a moderate pain produce by target lesion (4 on a scale of 0 to 10 over the prior 24 hours with or without pain killers intake) assessed during selection evaluation
- 4) Patients 18 years old
- 5) Able to give written consent
Key exclusion criteria (11 listed)
- Radiation therapy on the target tumor terminated < 3 weeks before treatment
- Any contra-indication for the procedure as stated by the radiologist in terms of tumor size, proximity to neural/vascular structures making the procedure at unacceptable risk
- Any contra-indication for the procedure as stated by the radiologist related to patient's condition (e.g. cardiac pacemakers) making the procedure at unacceptable risk
- Impaired haemostasis
- Concurrent participation in other experimental studies that could affect endpoints of this study
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 |
|---|---|---|
| Percutaneous RFASingle session percutaneous extra-spinal bone metastasis destruction to achieve pain relief | Procedure or surgery | RFA |
Primary outcome
Percentage of responding patients reporting an improvement of at least 3 points on item 3 "the worst pain in the last 24 hours" of Brief Pain Inventory (BPI) questionnaire
Time frame: 1 month
4 secondary outcomes
Comparison of the mean scores of the items 3, 5, 9B and 8 of the BPI questionnaire between the baseline and 6-month follow-up
Time frame: 6 months
Safety will be assessed according to SIR(11) / CTCAE classification
Time frame: 6 months
Mean scores variation of the morphine milligram equivalents (MME) (based on patient consumption diary) between the baseline and 6-month follow-up.
Time frame: 6 months
Percentage of responding patients defined by an improvement of at least 3 points on item 3 "the worst pain in the last 24 hours" of Brief Pain Inventory (BPI) questionnaire at 3 and 6 month follow-up.
Time frame: 6 months
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
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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.
Luigi Roberto CAZZATO, MD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous RFA in people with Multi-metastatic Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. 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: stopped early, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
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?
Percentage of responding patients reporting an improvement of at least 3 points on item 3 "the worst pain in the last 24 hours" of Brief Pain Inventory (BPI) questionnaire (time frame: 1 month). It is what the study was designed to measure, not a finding.
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 29 Aug 2024.