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Brain MetastasesPhase 3HipSterNCT04277403

HA-WBRT vs SRS in Patients With Multiple Brain Metastases

A Phase 3 study testing Hippocampal Avoiding Whole Brain Radiation Therapy with Simultaneous Integrated Boost and Single session or hypofractionated stereotactic radiosurgery in people with Brain Metastases, run by Medical University Innsbruck at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Metastases
What is being tested?
Hippocampal Avoiding Whole Brain Radiation Therapy with Simultaneous Integrated Boost and Single session or hypofractionated stereotactic radiosurgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteAustria
Study dates
15 Feb 2020to Feb 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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 locations and contacts

1 site in 1 country.

Julian Mangesius, MD contact

julian.mangesius@i-med.ac.at

Austria1 site, 1 recruiting

  • Medical University Innsbruck

    Innsbruck, 6020

    Julian Mangesius, MD, julian.mangesius@i-med.ac.at

    Ute Maria Ganswindt, MD, PhD

    Recruiting

Other trials in Austria

About this study

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

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

Read the 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.

Being tested
Hippocampal Avoiding Whole Brain Radiation Therapy with Simultaneous Integrated Boost, Single session or hypofractionated stereotactic radiosurgery
Keywords
brain metastases, hippocampal avoidance, radiosurgery
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hippocampal Avoiding Whole Brain Radiation Therapy with Simultaneous Integrated BoostRadiation

    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 radiosurgeryRadiation

    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.

Study groups in NCT04277403
Study groupRoleWhat they receive
HA-WBRT+SIBExperimentalHippocampal avoiding Whole brain radiation therapy (HA-WBRT) with volumetric modulated arc therapy (VMAT) with a simultaneously integrated boost (SIB) to each brain metastasis
Receives: Radiation: Hippocampal Avoiding Whole Brain Radiation Therapy with Simultaneous Integrated Boost
SRSActive comparatorSingle session or hypofractionated stereotactic radiosurgery (SRS) of multiple brain metastases
Receives: Radiation: Single session or hypofractionated stereotactic radiosurgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: up to 18 months

Secondary outcomes (7)

  1. Neurocognitive function assessed by VLMT

    Change of z-scores of VLMT (Verbaler Lern- und Merkfähigkeitstest) to baseline examination

    Measured: up to 18 months

  2. Neurocognitive function assessed by COWAT

    Change of z-scores of COWAT (controlled oral word association test) to baseline examination

    Measured: up to 18 months

  3. Neurocognitive function assessed by TMT

    Change of z-scores of TMT (trail making test) to baseline examination

    Measured: up to 18 months

  4. Local control rate

    rate of progression of treated metastases assessed in follow-up imaging (MRI, FET-PET)

    Measured: up to 18 months

  5. Survival time

    time from end of treatment to death

    Measured: up to 18 months

  6. 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

    Measured: up to 18 months

  7. 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

    Measured: up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2020
  2. Study start15 Feb 2020
  3. Primary completionFeb 2023 (estimated)
  4. Study completionFeb 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04277403
Sponsor's protocol ID
HIPSTER_2020
Acronym
HipSter
Status last verified
Sep 2021
First submitted
6 Feb 2020
Last updated
5 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hippocampal Avoiding Whole Brain Radiation Therapy with Simultaneous Integrated Boost and Single session or hypofractionated stereotactic radiosurgery in people with Brain Metastases, run by Medical University Innsbruck at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Julian Mangesius, MD (julian.mangesius@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracranial Progression free survival (time frame: up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04277403.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.

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