HA-WBRT vs SRS in Patients With Multiple Brain Metastases

Medical University Innsbruck150 enrolled

Overview

This study compares the effectiveness and safety of two radiation treatment techniques for patients with multiple brain metastases.

For patients suffering from multiple brain metastases whole brain radiation therapy still constitutes a standard therapy. However, because of the risk of neurocognitive side effects as well as reduced local tumor control, employment of stereotactic radiosurgery (SRS) is becoming more common. The disadvantage of SRS alone may be poor intracranial tumor control because of frequent appearance of new distant brain metastases after therapy. In recent years hippocampal avoidance whole brain therapy has been shown to minimize treatment related side effects while reducing the rate of distant intracranial failure. In this study patients will be randomized to receive either hippocampal avoidance whole brain radiation therapy with integrated tumor boost (HA-WBRT+SIB) or stereotactic radiosurgery. The investigators hypothesize that HA-WBRT+SIB can improve intracranial tumor control compared to stereotactic radiosurgery, while avoiding additional neurocognitive side effects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Brain Metastases

Interventions

Hippocampal Avoiding Whole Brain Radiation Therapy with Simultaneous Integrated BoostRADIATION

Hippocampal avoiding Whole brain radiation therapy (HA-WBRT) with volumetric modulated arc therapy (VMAT) with a prescribed dose of 30Gy in 12 fractions, 2.5Gy per fraction and a simultaneously integrated boost (SIB) to each brain metastasis of 51Gy to 95% of PTV in 12 Fractions, 4.25Gy per fraction.

Single session or hypofractionated stereotactic radiosurgeryRADIATION

Single session or hypofractionated stereotactic radiosurgery (SRS) of multiple brain metastases. Single session SRS will be delivered in 18 to 22Gy to the tumour encompassing 80% Isodose. Hypofractionated stereotactic radiosurgery (HfSRS) will be delivered in 5 sessions of 6Gy each to the tumour encompassing 80% isodose.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * At least 4 and not exceeding 15 brain metastases not exceeding a combined total volume of 25ml and not previously treated with radiotherapy * KPI ≥ 70, ECOG ≤ 2 * Age ≥ 18 years, Male or female Exclusion Criteria: * Neuroendocrine, SCLC, germinoma or lymphoma histology * Brain stem metastasis * Life expectancy \< 3 months * Suspicion of meningeosis carcinomatosa * Previous WBRT * Inability to participate in radiologic follow-up, contraindication to MR imaging (e.g. not MRI compatible pacemaker, severe claustrophobia) * Inability to participate in neurocognitive function testing, insufficient German language skills, aphasia, graphomotor impairment, insufficient vision, insufficient attention span * Pregnancy, nursing or unwillingness to prevent pregnancy using effective methods of contraception during treatment * Known abuse of medication, drugs or alcohol * Known severe dementia (z-score \< 2) or major cognitive function disorder that is not caused by intracranial tumour * Known clinical depression or psychotic disorder

Locations (1)

Medical University Innsbruck

Innsbruck, Austria

RECRUITING

Outcomes

Primary Outcomes

Intracranial Progression free survival

survival with freedom from both local and distant intracranial progression, measured in months from end of treatment until progression or death, assessed in follow-up imaging (MRI, FET-PET)

Time frame: up to 18 months

Secondary Outcomes

Neurocognitive function assessed by VLMT

Change of z-scores of VLMT (Verbaler Lern- und Merkfähigkeitstest) to baseline examination

Time frame: up to 18 months

Neurocognitive function assessed by COWAT

Change of z-scores of COWAT (controlled oral word association test) to baseline examination

Time frame: up to 18 months

Neurocognitive function assessed by TMT

Change of z-scores of TMT (trail making test) to baseline examination

Time frame: up to 18 months

Local control rate

rate of progression of treated metastases assessed in follow-up imaging (MRI, FET-PET)

Time frame: up to 18 months

Survival time

time from end of treatment to death

Time frame: up to 18 months

Quality of Life Score assessed by EORTC QLQ-C30 questionnaire

Change in Quality of Life Score of EORTC QLQ-C30 (Quality of life core module) relative to baseline

Time frame: up to 18 months

Quality of Life Score assessed by QLQ-BN20 questionnaire

Central Contacts

Julian Mangesius, MD

CONTACT

julian.mangesius@i-med.ac.at

Data from ClinicalTrials.gov

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