About this trial
The prospective, two-arm, randomized, controlled, multicentric phase III RENESANS trial is designed to compare the efficacy and safety of neoadjuvant stereotactic radiosurgery (Neo-SRS) versus multi-fraction stereotactic radiosurgery (mfSRS) in patients with large brain metastases, with the primary objective of evaluating the incidence of central nervous system composite events.
Eligibility criteria
Qualifiers
Age ≥18 years.
At least one brain metastasis appropriate for resection and not previously treated with SRS.
Lesions ≥2.5 cm and ≤6 cm in largest dimension.
Index lesion(s) will be treated, as outlined in the treatment section of the protocol.
Disqualifiers
No resectable lesion ≥2.5 cm.
Unresectable >4 cm lesion.
Previous whole brain irradiation.
Progressive brain lesion treated with SRS.
Trial design
Treatments tested in this trial
- Neoadjuvant Stereotactic Body Radiation Therapy (SBRT)
- Multi-fraction Stereotactic Body Radiation Therapy (SBRT)
Treatment groups
Locations
Sponsors and collaborators
Maciej Harat
Lead sponsor
Prof. Franciszek Lukaszczyk Memorial Oncology Center
Sponsor institution
Bydgoszcz University of Science and Technology
Collaborator