HA-WBRT vs SRS in Patients With Multiple Brain Metastases

NCT04277403 | Unknown Phase 3

• 1 other identifier: HIPSTER_2020
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Brain Metastases

Keywords

brain metastases; hippocampal avoidance; radiosurgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Neurocognitive function assessed by VLMT

  up to 18 months

• Neurocognitive function assessed by COWAT

  up to 18 months

• Neurocognitive function assessed by TMT

  up to 18 months

• Local control rate

  up to 18 months

• Survival time

  up to 18 months

Study Arms (2)

HA-WBRT+SIB

EXPERIMENTAL

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

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

SRS

ACTIVE COMPARATOR

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

Radiation: Single session or hypofractionated stereotactic radiosurgery

Interventions

Hippocampal Avoiding Whole Brain Radiation Therapy with Simultaneous Integrated Boost 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.

HA-WBRT+SIB

Single session or hypofractionated stereotactic radiosurgery 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.

SRS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University Innsbruck

Innsbruck, 6020, Austria

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Julian Mangesius, MD

CONTACT

julian.mangesius@i-med.ac.at

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Observer-blinding
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 20, 2020
• Study Start: February 15, 2020
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

AU (1)