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Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases

RECRUITINGN/ASponsored by Istituto Clinico Humanitas
Actively Recruiting
PhaseN/A
SponsorIstituto Clinico Humanitas
Started2023-01-31
Est. completion2027-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05545007

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Brain Metastases, AdultCancer

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