Bipolar RFA of Painful Extra-spinal Bone Metastases

Not Applicable

Terminated

• Conditions: Multi-metastatic Cancer

• Registration Number: NCT03738670
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-05
• Study First Submitted QC: 2018-11-09
• Study First Posted: 2018-11-13
• Study Start: 2019-06-12
• Primary Completion: 2021-12-02
• Study Completion: 2023-10-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Safety will be assessed according to SIR(11) / CTCAE classification	6 months
Mean scores variation of the morphine milligram equivalents (MME) (based on patient consumption diary) between the baseline and 6-month follow-up.	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.	6 months

Trial Locations

Locations (1)

University Hospital, Strasbourg, france; 🇫🇷 Strasbourg, France