Whole-brain irradiation with hippocampal sparing and dose escalation on metastases: neurocognitive testing and biological imaging
- Conditions
- C71Malignant neoplasm of brain
- Registration Number
- DRKS00004598
- Lead Sponsor
- niversitätsklinikum Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 136
1. Patient's written informed consent has been obtained
2. Age 18-80 years, male or female
3. Legal capacity, patient is able to understand the nature, significance, and consequences of the trial
4. At least 4 brain metastases of solid tumours, with at least one, but not exceeding 10 metastases = 5mm (i.e. eligible for dose escalation)
5. RPA classification I or II
6. No metastases (either preirradiated or not) and no resection cavity within the hippocampus or in a distance of 7mm to the hippocampus (= hippocampal avoidance region, HAR)
1. Simultaneous participation in other interventional trials which could interfere with this trial
2. Participation in a clinical trial within the last thirty days before the start of this trial, previous participation (randomisation) in this trial
3. Known or persistent abuse of medication, drugs or alcohol
4. Persons who are in a relationship of dependence/employment with the sponsor or the investigator
5. Pregnancy, nursing or patient not willing to prevent a pregnancy during treatment
6. Cerebral lymphomas, metastases of germ cell tumours, SCLC
7. Acute neurological symptoms demanding an immediate start of RT
8. CNS diseases or syndromes accompanied by cognitive deficits or radiological changes of the brain, e.g., dementia, major depression, clinically manifest hypertensive encephalopathy, meningiosis carcinomatosa
9. Previous brain irradiation (SRS/SFRT) of >1 brain metastasis >3cm or >3 brain metastases >1cm each
10. Previous brain irradiation <3 months before start of treatment
11. Previous surgical resection (± adjuvant SFRT) of >1 brain metastasis (biopsy allowed)
12. Previous surgical resection of 1 brain metastasis <4 weeks before start of treatment
13. Uncontrolled pretreated brain metastasis/-es after SRS/SFRT
14. Last application of chemotherapy/immunotherapy/targeted therapy <1 week before randomisation
15. RT planning conforming to OAR constraints not feasible (including previous cranial irradiation)
16. Benzodiazepines, barbiturates, topiramate, hydantoine as antiepileptic medication
17. > 1 brainstem metastasis =5mm
18. Brainstem metastasis >2cm
19. Brain metastasis >3.5cm
20. Resection cavity eligible for dose escalation >3.5cm
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eurocognitive function in 3 month survivors, measured by the difference between learning performance (Verbal Learning and Memory Test) at three months after radiation therapy and at baseline
- Secondary Outcome Measures
Name Time Method 1.Intracranial progression (local tumour progression, progression in the WBRT area without dose escalation, within hippocampus, overall; number of new cerebral metastases)<br>2.Extracranial progression<br>3.Overall survival<br>4.Death due to brain metastases<br>5.Locally progression-free survival<br>6.Progression-free survival <br>7.Changes in other cognitive performance measures<br>8.Depression<br>9.Health-related and individual quality of life<br>10.Morphological alterations on MRI<br>