BOREALIS

BOne metastases REgistry for patients undergoing cryoAbLation with curatIve purpoSe

Status: enrolling

Study summary | Objectives and outcome measures | Patient enrolment | Steering committee | Links

Study summary

BOREALIS is a prospective, multicentre, single-arm observational cohort study that aims to expand the evidence-base for cryoablation of bone metastases in patients with oligometastatic or bone oligo-progressive disease from solid tumours planned to be treated with curative-intent.

Objectives and outcome measures

The primary objective of BOREALIS is to understand the effectiveness of curative-intent cryoablation in preventing the progression of bone metastases in patients with oligometastatic or bone oligo-progressive disease from solid tumours.

The primary outcome measure is local progression-free survival rate at twelve months, on a per lesion basis.

As secondary objectives, BOREALIS aims to assess the feasibility of comprehensive standard-of-care (SOC) patient management combining diagnosis through biopsy, treatment with cryoablation and fracture prevention through bone consolidation in one session. Other secondary objectives are the impact of cryoablation in eradicating bone metastases, the effect of the treatment on different survivals, the potential of the treatment to prevent fractures at treated sites and the need for systemic therapy, safety and the impact of the procedure on patient pain and quality of life.

Secondary outcome measures assessing the technical feasibility and long-term effectiveness include:

• Complete local tumour response at 12 months;
• Fracture-free survival and fracture-free survival rate at 12 months;
• Target-bone metastasis progression-free survival;
• Bone-disease progression-free survival;
• Extraosseous disease progression-free survival;
• Overall progression-free survival;
• Overall survival;
• Systemic therapy-free survival.

Safety and patient-reported outcome measures will be assessed using:

• Adverse events (CTCAE) version 5.0;
• Brief pain questionnaire (MD Anderson Cancer Center) and QLQ-C30.

Patient enrolment

The enrolment of patients started in April 2025 with the recruitment of sites from Spain and France. The BOREALIS team is working on onboarding additional sites from Switzerland, France, Greece, and the US. Patient enrolment will last for two years or until 50 patients are included in the study. After patient enrolment is complete, another year will be used for data collection to reach the planned follow-up.

Steering committee

Links

https://clinicaltrials.gov/study/NCT06480955