Clinical trial NCT06480955: BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe
Official title: BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bone Metastases
Keywords: Cryoablation Oligo-progressive disease
Bone metastases
Oligometastatic Disease
Oligo-progressive disease
Lead sponsor: Cardiovascular and Interventional Radiological Society of Europe
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2024-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with bone metastases from oligometastatic or bone oligo-progressing disease from solid tumours treated with curative-intent cryoablation may participate in BOREALIS. Patients from vulnerable populations (e.g., minors, pregnant women, incapacitated or unconscious individuals) shall not be included in the study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Local progression-free survival rate
timeFrame: 12 months
Secondary outcomes:
measure: Technical feasibility
timeFrame: Periprocedurally
measure: Adverse events
timeFrame: Through study completion
measure: Complete local tumour response
timeFrame: 12 months
measure: Fracture-free survival
timeFrame: End of study
measure: Fracture-free survival rate
timeFrame: Until the end of the follow-up period (1 year)
measure: Bone-disease progression-free survival
timeFrame: Until the end of the follow-up period (1 year)
measure: Extraosseous disease progression-free survival
timeFrame: Until the end of the follow-up period (1 year)
measure: Overall progression-free survival
timeFrame: Until the end of the follow-up period (1 year)
measure: Overall survival
timeFrame: Until the end of the follow-up period (1 year)
measure: Systemic therapy-free survival
timeFrame: Until the end of the follow-up period (1 year)
measure: Impact on patient pain
timeFrame: 1, 3, 6, 12 months
measure: Impact on patient quality of life
timeFrame: 1, 3, 6, 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Strasbourg University Hospitals, Strasbourg, France
name: Roberto L Cazzato, Dr
role: STUDY_CHAIR
References: