C79.3
Conditions
Interventions
Group 1: Eligible patients with suspected supratentorial brain metastases are discussed in a multidisciplinary neuro-oncological tumor board and screened for participation. After written informed cons
Sponsors
Universitätsklinikum Bonn
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Confirmed or highly suspected supratentorial brain metastasis Eastern Cooperative Oncology Group (ECOG) performance status 0–2 = 10 brain metastases at the time of planned surgery Anticipated gross total resection at the discretion of the treating neurosurgeon Intraoperative frozen-section diagnosis consistent with metastasis from a solid tumor Written informed consent Ability and willingness to comply with scheduled follow-up examinations
Exclusion criteria
Exclusion criteria: Prior intracranial radiotherapy Predicted violation of organ-at-risk dose constraints (e.g., optic nerves, optic chiasm, brainstem) based on preoperative MRI Evidence of leptomeningeal metastasis More than 10 brain metastases ECOG performance status > 2 Pregnancy or breastfeeding Inability to provide informed consent Severe comorbidities precluding surgery or intraoperative radiotherapy in the judgment of the treating physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of image-guided intraoperative radiotherapy, defined as successful completion of intraoperative cone-beam CT verification and IORT delivery as planned, combined with quantitative dosimetric assessment of applicator–cavity contact. This includes measurement of air-gap volume and reconstructed dose distribution (e.g., brain V12Gy and minimum dose within air pockets) based on postoperative Monte Carlo dose simulation. Assessment time frame: intraoperative and immediate postoperative period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Local control of the resection cavity Absence of radiographic progression within 1 cm of the IORT-treated cavity according to RANO-BM criteria. Time frame: assessed every 3 months up to 12 months after surgery. Distant brain progression Occurrence of new or progressive intracranial metastases outside the treated cavity. Time frame: assessed every 3 months up to 12 months. Leptomeningeal disease (LMD) Radiographic or cytologic evidence of leptomeningeal tumor spread. Time frame: up to 12 months. Radiation necrosis (RN) Diagnosis of RN based on imaging, PET, or histopathology. Time frame: up to 12 months. Overall survival (OS) Time from surgery to death from any cause. Time frame: up to 12 months. Perioperative and treatment-related toxicity Cranial surgery–related complications and adverse events graded according to CTCAE v5.0. Time frame: acute (=90 days) and late (>90 days). Rate of applicator repositioning Frequency of second CBCT and intraoperative adjustment due to air gaps. Time frame: intraoperative. | — |
Countries
Germany
Contacts
Public ContactGustavo R. Sarria
Universitätsklinikum Bonn
Outcome results
None listed