HA-WBRT vs SRS in Patients With Multiple Brain Metastases

NCT ID: NCT04277403

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-15
• Study Completion Date: 2023-02-28

Brief Summary

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

Detailed 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.

Conditions

Brain Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HA-WBRT+SIB

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

Group Type: EXPERIMENTAL

Hippocampal Avoiding Whole Brain Radiation Therapy with Simultaneous Integrated Boost

Intervention Type: RADIATION

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.

SRS

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

Group Type: ACTIVE_COMPARATOR

Single session or hypofractionated stereotactic radiosurgery

Intervention Type: RADIATION

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.

Interventions

Hippocampal Avoiding Whole Brain Radiation Therapy with Simultaneous Integrated Boost

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.

Intervention Type: RADIATION

Single session or hypofractionated stereotactic radiosurgery

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.

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University Innsbruck

Innsbruck, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Julian Mangesius, MD

Role: CONTACT

julian.mangesius@i-med.ac.at

Facility Contacts

Julian Mangesius, MD

Role: primary

julian.mangesius@i-med.ac.at

Other Identifiers

HIPSTER_2020

Identifier Type: -

Identifier Source: org_study_id