NCT05101824

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Gitte Fredberg Persson MD PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Oligometastatic Disease
• Bone Metastases
• Stereotactic Body Radiotherapy

Interventions

Type	Name	Description
RADIATION	SABR	Two fractionation regimes are available (37.5 Gy in 3 fractions and 30.0 Gy in 3 fractions)

Timeline

• Start date: 2019-11-01
• Primary completion: 2023-01-13
• Completion: 2027-11-01
• First posted: 2021-11-01
• Last updated: 2023-07-11

Locations

6 sites across 2 countries: Denmark, Norway