Radiosurgery With or Without Whole Brain Radiation for Multiple Metastases

Titre officiel

A Randomized Trial Evaluating Stereotactic Radiosurgery Alone (SRS) to Whole Brain Radiation Therapy (WBRT) Plus SRS for Patients With 5 to 20 Brain Metastases

Sommaire:

This clinical study is a randomized, non-blinded, single-centre trial in patients presenting with 5 to 20 brain metastases. Eligible patients will be randomized to receive either stereotactic radiosurgery (SRS) alone or SRS plus whole brain radiation (WBRT).

Description de l'essai

Primary Outcome:

• Neurocognitive function

Secondary Outcome:

• Neurocognitive function - HVLT-R
• Neurocognitive function - Trail Making Test
• Neurocognitive function - Controlled Oral Word Association
• Neurocognitive function - Clinical Trial Battery Composite
• Local control of sites initially treated by SRS
• Distant tumour control within the brain
• Overall central nervous system (CNS) response
• Overall survival
• Measure of Quality of Life
• Incidence of Brain Salvage therapy During Follow-up

The current standard of care for patients with limited brain metastases (1 to 4) is stereotactic radiosurgery (SRS) alone. This has evolved from the traditional standard of care in treating patients with whole brain radiation (WBRT). Studies in patients with limited (less than 5) brain metastases have shown that WBRT is harmful with respect to neurocognition and does not improve patient survival compared to SRS alone. As a result, SRS alone now is considered the standard of care treatment for patients with limited metastases. However, there is a lack of high quality prospective randomized evidence on the role of SRS in patients with 5 or more brain metastases to guide treatment. Therefore, this study seeks to compare SRS alone versus SRS plus WBRT in patients with 5 to 20 brain metastases in a randomized, non-blinded, single-centre trial.

Voir cet essai sur ClinicalTrials.gov