HA-WBRT vs SRS in Patients With Multiple Brain Metastases

Brain Metastases Clinical Trial

— HipSter  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04277403
• Other study ID #: HIPSTER_2020
• Status: Recruiting
• Phase: Phase 3
• Start date: February 15, 2020
• Est. completion date: February 2023

Study information

• Verified date: September 2021
• Source: Medical University Innsbruck
• Contact: Julian Mangesius, MD
• Email: julian.mangesius[@]i-med.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Radiation:
• 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.
• 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.

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	up to 18 months
Secondary	Neurocognitive function assessed by VLMT	Change of z-scores of VLMT (Verbaler Lern- und Merkfähigkeitstest) to baseline examination	up to 18 months
Secondary	Neurocognitive function assessed by COWAT	Change of z-scores of COWAT (controlled oral word association test) to baseline examination	up to 18 months
Secondary	Neurocognitive function assessed by TMT	Change of z-scores of TMT (trail making test) to baseline examination	up to 18 months
Secondary	Local control rate	rate of progression of treated metastases assessed in follow-up imaging (MRI, FET-PET)	up to 18 months
Secondary	Survival time	time from end of treatment to death	up to 18 months
Secondary	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	up to 18 months
Secondary	Quality of Life Score assessed by QLQ-BN20 questionnaire	Change in Quality of Life Score of QLQ-BN20 (quality of life brain cancer module) relative to baseline	up to 18 months