Bony M - Stereotactic Ablative Radiotherapy (SABR) of Bony Metastases in Patients With Oligometastatic Disease

Gitte Fredberg Persson MD PhD

Status

Active, not recruiting

Conditions

Oligometastatic Disease

Stereotactic Body Radiotherapy

Bone Metastases

Treatments

Radiation: SABR

Study type

Interventional

Funder types

Other

Identifiers

NCT05101824

H-19039071

Details and patient eligibility

About

This is a prospective, investigator-initiated, phase II, multicentre-study, investigating the efficacy and toxicity of definitive SABR of osseous oligometastases, when pragmatically introduced into a daily clinical setting.

Full description

Patients with a histology or cytology proven non-hematological cancer and at least one lesion in the bones are eligible.

Patients with de novo- and induced oligometastatic disease, as well as patients with oligo-recurrence or oligo-progression disease can be included. A total of 67 patients will be enrolled.

The overall aim is to document long time follow-up in respect to local control rate, OS, PFS, rate of symptomatic skeletal event at the irradiated site(s), time to progression outside the radiation field at 1-, 2- and 5-years and acute/ late toxicities.

The primary endpoint is the rate of local control 1-year post SABR. Patients will have a CT scan and a clinical evaluation every 3 month after SABR according to the standard clinical follow-up program.

During the 1 year follow-up we also perform pain assessment (using the Numeric Pain Rating Scale), report the analgesic consumption and Quality of life (QoL) measured with EQ-5D-5L.

Two dose levels are offered with either 37.5 gy in 3 fractions or 30 gy in 3 fractions, prescribed to the GTV.

Enrollment

67 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histology or cytology proven non-haematological cancer.
At least one lesion in the bones is required.
ECOG performance status ≤ 2.
≥ 18 years old.
Life expectancy > 6 months.
GTV diameter ≤ 5 cm.
In case of de novo OMD and OMD recurrence a maximum of 5 targets (including the primary tumour) in a maximum of 3 organ sites are allowed.
In case of OPD * and induced OMD*2 only 3 metastases (including the primary tumour) are allowed.
The metastatic lesion(s) must be visible on a CT- or MR- scan and suitable for treatment with SABR.
All metastatic sites are treated or planned for ablative therapy (including surgery) - for OPD only the sites in progression is required to fulfil this criterion. • A baseline scan within 28 days of inclusion (CT or PET- CT).
For spine/paraspinal targets, an MR scan is mandatory, if epidural growth cannot be precluded on the baseline CT scan.
No curative intended treatment option available.
An ablative strategy should be deemed clinically relevant and is at the discretion of the treating physician to decide.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

Patient cannot tolerate physical set up required for SABR.
Uncontrolled intercurrent illness.
Pregnancy.
Bilsky score ≥ 1b. If the patient is treated with surgery, a pre-operative Bilsky score ≥ 1b is an exclusion criterion as well. See appendix A for Bilsky score.
Presence of myelopathy from the target area.
Candidate for surgical treatment (determined by the institutions clinical oncologist, neurosurgeon or orthopaedic surgeon).
For spine/paraspinal lesions where epidural growth cannot be precluded on the baseline CT scan: patients for whom an MR scan is contraindicated.
Mechanical instability and/or fracture risk *3.
For spine disease, involvement of ≥ three contiguous vertebrae.
Uncontrolled disease in respect to malignant pleural effusion, ascites, lymphangitic carcinomatosis, pleural carcinomatosis or peritoneal carcinomatosis.
Patients with uncontrolled brain metastases.
If the patient has received previous radiotherapy, the combined dose at the radiation site must not exceed the dose constraints according to Appendix B. -