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UnknownNCT04277403

HA-WBRT vs SRS in Patients With Multiple Brain Metastases

Hippocampal Avoidance Whole Brain Radiotherapy (HA-WBRT) and Stereotactic Radiosurgery (SRS) in Patients With Multiple Brain Metastases

Status
Unknown
Phase
Phase 3
Study type
Interventional
Enrollment
150 (estimated)
Sponsor
Medical University Innsbruck · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
RADIATIONHippocampal Avoiding Whole Brain Radiation Therapy with Simultaneous Integrated BoostHippocampal 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.
RADIATIONSingle session or hypofractionated stereotactic radiosurgerySingle 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.

Timeline

Start date
2020-02-15
Primary completion
2023-02-01
Completion
2023-02-01
First posted
2020-02-20
Last updated
2021-09-05

Locations

1 site across 1 country: Austria

Source: ClinicalTrials.gov record NCT04277403. Inclusion in this directory is not an endorsement.