Evaluation of Neoadjuvant Stereotactic Radiosurgery (SRS) and Multi-fraction SRS Alone for the Treatment of Large Brain Metastases

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaciej Harat

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

98 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Maciej Harat

Lead sponsor

Prof. Franciszek Lukaszczyk Memorial Oncology Center

Sponsor institution

Bydgoszcz University of Science and Technology

Collaborator