bony m - stereotactic ablative radiotherapy (sabr) of bony metastases in patients with oligometastatic disease

Conditions: Oligometastatic Disease; Bone Metastases; Stereotactic Body Radiotherapy

Summary: 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.

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.

Eligibility criteria:
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. -