RecruitingNot ApplicableNCT05545007

Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases

Phase III Randomized Trial Comparing Preoperative Hypofractionated Radiosurgery (HSRS) to Postoperative Hypofractionated Radiosurgery (HSRS) for Patients With Large Brain Metastases (= 2.1cm) Suitable for Surgical Resection

Sponsor

Istituto Clinico Humanitas

Enrollment

146 participants

Start Date

Jan 31, 2023

Study Type

INTERVENTIONAL

Conditions

Brain Metastases, Adult

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

Min Age: 18 Years

Inclusion Criteria9

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 Criteria7

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

Interventions

RADIATIONHypofractionated Radiosurgery (HSRS)

HSRS converges multiple radiation beams to deliver a single, large dose of radiation to a discrete tumor target with high precision, thereby minimizing radiation dose to the surrounding normal tissue.

PROCEDUREBrain metastases surgical resection

Complete surgical resection of brain lesions with adeguate margins.