Clinical trial NCT04277403: HA-WBRT vs SRS in Patients With Multiple Brain Metastases
Official title: Hippocampal Avoidance Whole Brain Radiotherapy (HA-WBRT) and Stereotactic Radiosurgery (SRS) in Patients With Multiple Brain Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Brain Metastases
Keywords: brain metastases
hippocampal avoidance
radiosurgery
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Intracranial Progression free survival
timeFrame: up to 18 months
Secondary outcomes:
measure: Neurocognitive function assessed by VLMT
timeFrame: up to 18 months
measure: Neurocognitive function assessed by COWAT
timeFrame: up to 18 months
measure: Neurocognitive function assessed by TMT
timeFrame: up to 18 months
measure: Local control rate
timeFrame: up to 18 months
measure: Survival time
timeFrame: up to 18 months
measure: Quality of Life Score assessed by EORTC QLQ-C30 questionnaire
timeFrame: up to 18 months
measure: Quality of Life Score assessed by QLQ-BN20 questionnaire
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
Study officials:
References: