C79.3
Conditions
Interventions
Group 1: Single-fraction stereotactic radiosurgery (SRS) with a total dose of 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm), respectively, delivered to the margin of the metastasis according to RTOG 9005 g
Sponsors
Universitätsklinikum Erlangen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age = 18 years (no upper age limit) 2. Karnofsky Performance Scale (KPS) score >50 3. Life expectancy > 3 months 4. 1 to 10 brain metastases from a solid tumor 5. Indication for local radiotherapy of one or more brain metastases measuring 2 to 4 cm in diameter 6. Ability to understand the contents of the protocol and consent to participate, in writing 7. Written informed consent before enrollment in the study
Exclusion criteria
Exclusion criteria: 1. Whole brain radiotherapy completed = 6 weeks before study treatment or planned whole brain radiotherapy following local radiotherapy 2. Prior radiotherapy of the metastasis or metastases to be irradiated in the present study 3. Relevant overlap of prior radiotherapy fields, cerebral or otherwise, with the metastasis or metastases to be irradiated in the present study 4. Location of metastasis to be irradiated in the brainstem. 5. Contraindications to magnetic resonance imaging (e.g., metal implants, cardiac pacemaker, claustrophobia) 6. If a metastasis to be irradiated cannot be adequately differentiated in high-resolution, contrast-enhanced T1-weighted imaging for target volume delineation 7. Pregnant or nursing women 8. Women and men of reproductive age who are unwilling or unable to ensure reliable contraception during treatment 9. Chronic drug, medication or alcohol abuse 10. Psychological, familial, sociological, or geographical condition that would preclude study compliance 11. Nursing care patients 12. Inability to speak and understand German 13. Simultaneous participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of local control of irradiated brain metastases Primary endpoint: Time to local progression - TTLP Local progression will be defined according to the RANO BM (Response assessment in neuro-oncology Brain Metastases) criteria by an increase of at least 20% in the longest diameter of the metastasis relative to nadir or baseline. In addition to the relative increase of 20% the lesion must increase by an absolute value of 5 mm or more. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of the tolerability of local radiotherapy, as measured based on the endpoints CNS toxicity and, in particular, radiation necrosis in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (Assessments 6 weeks and 3 months after radiotherapy, then every 3 months for a total of 24 months) Improvement of the local control of irradiated brain metastases, as determined based on volumetric criteria. Volumetric criteria may have important methodological advantages over traditional endpoints for the identification of treatment failure, especially in the case of large brain metastases. This study aims to improve our understanding of volumetric criteria and helps to further establish them. (MRI 6 weeks and 3 months after radiotherapy, then every 3 months for a total of 24 months) Quality of Life (EORTC QLQ-C30 and QLQ-BN20) (Assessments 6 weeks and 3 months after radiotherapy, then every 3 months for a total of 24 months) Improvement of local progression-free survival Improvement of overall survival | — |
Countries
Germany
Contacts
Public ContactFlorian Putz
Universitätsklinikum Erlangen
Outcome results
None listed