HA-WBRT vs SRS in Patients With Multiple Brain Metastases (HipSter)

Medical University Innsbruck

Status and phase: Unknown; Phase 3

Conditions: Brain Metastases

Treatments: Radiation: Single session or hypofractionated stereotactic radiosurgery; Radiation: Hippocampal Avoiding Whole Brain Radiation Therapy with Simultaneous Integrated Boost

Study type: Interventional

Funder types: Other

Identifiers

NCT04277403

HIPSTER_2020

Details and patient eligibility

About

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

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

HA-WBRT+SIB

Experimental group

Description:

Hippocampal avoiding Whole brain radiation therapy (HA-WBRT) with volumetric modulated arc therapy (VMAT) with a simultaneously integrated boost (SIB) to each brain metastasis

Treatment:

Radiation: Hippocampal Avoiding Whole Brain Radiation Therapy with Simultaneous Integrated Boost

SRS

Active Comparator group

Description:

Single session or hypofractionated stereotactic radiosurgery (SRS) of multiple brain metastases

Treatment:

Radiation: Single session or hypofractionated stereotactic radiosurgery