Bone Metastases
Conditions
Keywords
Cryoablation Oligo-progressive disease, Bone metastases, Oligometastatic Disease, Oligo-progressive disease
Brief summary
BOREALIS is a multicentre, prospective, observational cohort study designed to investigate the effectiveness, feasibility, safety and impact on pain and quality of life of curative-intent cryoablation for the treatment of bone metastases in patients with oligometastatic or bone oligo-progressive disease.
Interventions
DEVICECryoablation system
Any cryoablation system from Boston Scientific that has received CE Mark and/or FDA clearance for the ablation of bone malignancies.
Sponsors
Boston Scientific Corporation
Cardiovascular and Interventional Radiological Society of Europe
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Bone metastases in patients with oligometastatic disease (\<5 bone/visceral metastases) or bone oligo-progressive disease (visceral or osseous multi-metastatic disease stable under systemic treatment except 1-3 progressing bone metastases) from solid tumours; * Number of target lesions ≤ 3 * Size of target lesion(s) \< 5 cm (largest diameter); * Referral to local ablative treatment by multidisciplinary tumour board (MDTB); * Treatment by percutaneous cryoablation with curative intent (i.e., complete tumour destruction) assessed as technically feasible by the IR in charge; * Procedure performed with a cryoablation system from Boston Scientific.
Exclusion criteria
* \< 18 years old; * Incapacity or refusal to give informed consent; * Ongoing pregnancy; * Health status not compatible with the minimum meaningful follow-up period (i.e., 12 months): * Karnofsky Performance Scale \< 60%, or * Bone metastases originating from rapidly evolving tumour histologies not allowing reasonable life expectancy of at least 12 months, or * Life expectancy \< 12 months * Infection of treatment site or systemic infection; * Uncorrectable coagulopathy; * Haematological disease (including multiple myeloma and plasmacytoma); * Concomitant radiation therapy or radiation therapy within 12 weeks before the planned cryoablation procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local progression-free survival rate | 12 months | On a per lesion basis, proportion of target lesions free from local tumour progression using the Kaplan Meier estimate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Through study completion | Incidence and severity of adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
| Complete local tumour response | 12 months | On a per lesion basis, proportion of target lesions with complete response status |
| Fracture-free survival | End of study | On a per lesion basis,time between cryoablation and fracture at treated site |
| Fracture-free survival rate | Until the end of the follow-up period (1 year) | On a per lesion basis, proportion of target lesion(s) free from fracture |
| Bone-disease progression-free survival | Until the end of the follow-up period (1 year) | Time between cryoablation and progression in the bone (incl. new lesions) |
| Technical feasibility | Periprocedurally | Adherence to a comprehensive SOC treatment protocol that includes i) peri-operative biopsy if indicated, ii) cryoablation, and iii) bone consolidation through osteoplasty or osteosynthesis if biomechanically indicated |
| Overall progression-free survival | Until the end of the follow-up period (1 year) | Time between cryoablation and any progression (incl. new lesions) or death |
| Overall survival | Until the end of the follow-up period (1 year) | Time between cryoablation and death |
| Systemic therapy-free survival | Until the end of the follow-up period (1 year) | Time between cryoablation and the next systemic treatment (excluding any adjuvant treatment that was part of the patient's treatment plan) |
| Impact on patient pain | 1, 3, 6, 12 months | Patient-reported pain assessment using the Brief Pain Inventory - short form |
| Impact on patient quality of life | 1, 3, 6, 12 months | Patient-reported quality of life assessment using the EORTC QLQ-C30 questionnaire |
| Extraosseous disease progression-free survival | Until the end of the follow-up period (1 year) | Time between cryoablation and extra-osseous progression (incl. new lesions) |
Countries
France, Spain, Switzerland
Contacts
Primary ContactClaire E Poulet, PhD
Backup ContactDhwani S. Korde, PhD
Outcome results
None listed