Multi-metastatic Cancer Clinical Trial
— PERFACOOLOfficial title:
Pain Evaluation After Treatment of Extra-spinal Bone Metastases With OsteoCOOL Radiofrequency (RF) Ablation System
| NCT number | NCT03738670 |
| Other study ID # | 7010 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 12, 2019 |
| Est. completion date | July 2024 |
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.
| Status | Recruiting |
| Enrollment | 65 |
| Est. completion date | July 2024 |
| Est. primary completion date | January 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: 1. Radiation therapy on the target tumor terminated < 3 weeks before treatment 2. 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 3. 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 4. Impaired haemostasis 5. Concurrent participation in other experimental studies that could affect endpoints of this study 6. Contraindication to any form of sedation/anaesthesia 7. Signs of local/systemic infection identified before procedure, in accordance with standard care 8. Sclerotic metastases 9. Adults under guardianship 10. Patients under judicial protection 11. Pregnant or breastfeeding woman |
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital, Strasbourg, france | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 1 month | ||
| Secondary | 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 | 6 months | ||
| Secondary | Safety will be assessed according to SIR(11) / CTCAE classification | 6 months | ||
| Secondary | Mean scores variation of the morphine milligram equivalents (MME) (based on patient consumption diary) between the baseline and 6-month follow-up. | 6 months | ||
| Secondary | 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. | 6 months |