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HA-WBRT vs SRS in Patients With Multiple Brain Metastases (HipSter)

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ClinicalTrials.gov Identifier: NCT04277403
Recruitment Status : Recruiting
First Posted : February 20, 2020
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
Medical University Innsbruck

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

Condition or disease Intervention/treatment Phase
Brain Metastases Radiation: Hippocampal Avoiding Whole Brain Radiation Therapy with Simultaneous Integrated Boost Radiation: Single session or hypofractionated stereotactic radiosurgery Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: Observer-blinding
Primary Purpose: Treatment
Official Title: Hippocampal Avoidance Whole Brain Radiotherapy (HA-WBRT) and Stereotactic Radiosurgery (SRS) in Patients With Multiple Brain Metastases
Actual Study Start Date : February 15, 2020
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Arm Intervention/treatment
Experimental: 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
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.

Active Comparator: SRS
Single session or hypofractionated stereotactic radiosurgery (SRS) of multiple brain metastases
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.




Primary Outcome Measures :
  1. Intracranial Progression free survival [ Time Frame: up to 18 months ]
    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)


Secondary Outcome Measures :
  1. Neurocognitive function assessed by VLMT [ Time Frame: up to 18 months ]
    Change of z-scores of VLMT (Verbaler Lern- und Merkfähigkeitstest) to baseline examination

  2. Neurocognitive function assessed by COWAT [ Time Frame: up to 18 months ]
    Change of z-scores of COWAT (controlled oral word association test) to baseline examination

  3. Neurocognitive function assessed by TMT [ Time Frame: up to 18 months ]
    Change of z-scores of TMT (trail making test) to baseline examination

  4. Local control rate [ Time Frame: up to 18 months ]
    rate of progression of treated metastases assessed in follow-up imaging (MRI, FET-PET)

  5. Survival time [ Time Frame: up to 18 months ]
    time from end of treatment to death

  6. Quality of Life Score assessed by EORTC QLQ-C30 questionnaire [ Time Frame: up to 18 months ]
    Change in Quality of Life Score of EORTC QLQ-C30 (Quality of life core module) relative to baseline

  7. Quality of Life Score assessed by QLQ-BN20 questionnaire [ Time Frame: up to 18 months ]
    Change in Quality of Life Score of QLQ-BN20 (quality of life brain cancer module) relative to baseline



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04277403


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

Locations
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Austria
Medical University Innsbruck Recruiting
Innsbruck, Austria, 6020
Contact: Julian Mangesius, MD       julian.mangesius@i-med.ac.at   
Principal Investigator: Ute Maria Ganswindt, MD, PhD         
Sub-Investigator: Julian Mangesius, MD         
Sponsors and Collaborators
Medical University Innsbruck
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Responsible Party: Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT04277403    
Other Study ID Numbers: HIPSTER_2020
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University Innsbruck:
brain metastases
hippocampal avoidance
radiosurgery
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases