Brain Metastases
Conditions
Keywords
fractionated stereotactic radiotherapy
Brief summary
Randomized phase II trial. The study aims to investigate a different and potentially safer radio therapeutic treatment method for brain metastases. The current standard of stereotactic radiotherapy (SRT) in one or three fractions is compared to fractionated stereotactic radiotherapy (fSRT) in five fractions.
Detailed description
Randomized phase II trial. Stereotactic radiotherapy is one of the most frequently chosen treatment options for brain metastases. There are an increasing number of long term survivors. Brain necrosis (e.g. radio necrosis) is the most important long term side effect of the treatment, occurring in up to 40% of patients, dependent on the size of the metastasis and delivered radiotherapy dose. Retrospective studies have shown that the incidence of radio necrosis, as well as local tumor recurrence, can be decreased with a risk difference of around 20% by administrating fractionated stereotactic radiotherapy (fSRT, e.g. five fractions) over single fraction stereotactic radiotherapy, especially in large brain metastases. In this trial, one group is treated with SRT in one or three fractions. The other group is treated with fSRT in five fractions. Survival, toxicity and patient reported quality of life are monitored.
Sponsors
Haaglanden Medical Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1:1 randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * At least one brain metastasis of large cell cancer suitable for SRT * Karnofsky Performance Status ≥ 70 * Ability to provide written informed consent * New brain metastases during follow-up after surgery allowed (when outside of resection cavity area) * New brain metastases during follow-up after previous SRT allowed (when outside of previous irradiation field)
Exclusion criteria
* Contra-indication for MRI scan * Primary tumor of small cell lung cancer, germinoma or lymphoma * Prior whole brain radiotherapy or SRT on the current target brain metastases (in field re-irradiation) * Presence of leptomeningeal metastases * Previous inclusion in the SAFESTEREO study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| radio necrosis or local failure | 2 years after treatment | Incidence of either radio necrosis or local failure according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| symptomatic radio necrosis (RN) or local failure (LF) | 2 years after treatment | incidence of RN or LF within 2 years after SRT |
| salvage treatment | 2 years after treatment | incidence of salvage treatment within 2 years after SRT |
| distant brain recurrences | 2 years after treatment | incidence of distant brain recurrences within 2 years after SRT |
| Survival | 2 years after treatment | median survival with Kaplan Meyer analysis |
| Anti-epileptic drug use | baseline - 2 years after treatment | Anti-epileptic drug use in mg per day |
| Grade 2 or more toxicity (CTCAE v5.0) | baseline - 2 years after treatment | incidence of Grade 2 or more toxicity according to CTCAE version 5.0 within 2 years after SRT |
| Dose dexamethasone | baseline - 2 years after treatment | Dose dexamethasone in mg per day |
Countries
Netherlands
Contacts
Primary ContactJaap D Zindler, MD, PhD
Backup ContactMirjam Mast, PhD
Outcome results
None listed