Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases (NCT05545007) | Clinical Trial Compass
RecruitingNot Applicable
Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases
Italy146 participantsStarted 2023-01-31
Plain-language summary
This is a phase III randomized trial with the aim to compare preoperative HSRS to postoperative HSRS in patients with large at least one BMs from solid tumors suitable for surgical resection.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>18 years
* Histological or cytological or radiological confirmation of solid tumor malignancy
* Clinical indication for surgical resection of one brain metastasis
* Karnosky performance status (KPS) ≥70
* Controlled or responsive extra cranial metastatic lesions
* Limited brain metastases (1-4 BMs)
* Single metastatic lesion ≥ 2.1 cm in maximum diameter (4 cm3)
* Lesions ≤2 cm conditioning mass effect or neurological deficits or massive edema unresponsive to steroids
* Written informed consent form
Exclusion Criteria:
* Prior WBRT
* KPS \< 70
* Diagnosis of small cell lung cancer (SCLC), germinal cell tumour or Lymphoproliferative disease
* Pregnant women
* Prior open neurosurgery for malignancy
* More than 4 brain metastases
* Patients with incompatibility to perform MRI