Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study compares the effectiveness and safety of two radiation treatment techniques for patients with multiple brain metastases.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| SRS | Active Comparator | Single session or hypofractionated stereotactic radiosurgery (SRS) of multiple brain metastases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive function assessed by VLMT | Change of z-scores of VLMT (Verbaler Lern- und Merkfähigkeitstest) to baseline examination | up to 18 months |
| Neurocognitive function assessed by COWAT |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julian Mangesius, MD | Contact | julian.mangesius@i-med.ac.at |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Innsbruck | Recruiting | Innsbruck | 6020 | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Observer-blinding
|
| 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. |
|
Change of z-scores of COWAT (controlled oral word association test) to baseline examination
| up to 18 months |
| Neurocognitive function assessed by TMT | Change of z-scores of TMT (trail making test) to baseline examination | up to 18 months |
| Local control rate | rate of progression of treated metastases assessed in follow-up imaging (MRI, FET-PET) | up to 18 months |
| Survival time | time from end of treatment to death | up to 18 months |
| 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 |
| 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 |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |