Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases

Launched by ISTITUTO CLINICO HUMANITAS · Sep 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different approaches to treating patients with large brain metastases, which are cancerous tumors that have spread to the brain from other parts of the body. The trial aims to compare receiving focused radiation therapy before surgery (preoperative) versus after surgery (postoperative) for patients who have at least one large brain metastasis that can be surgically removed.

To be eligible for this trial, participants should be adults over 18 years old who have a confirmed diagnosis of a solid tumor and a clinical need for surgery to remove one brain metastasis. They should also have a good overall health status, meaning they can carry out daily activities with minimal assistance. Participants will be asked to provide informed consent before joining the study, and they can expect to be randomly assigned to either the preoperative or postoperative treatment group. This trial is currently recruiting participants and aims to understand which timing of radiation therapy might be more effective for improving outcomes in patients with large brain metastases.

Gender

ALL

Eligibility criteria

• 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