Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SRT, fSRT.
- Who it may be relevant to
- Registry conditions: Brain Metastases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Radiation SRT
SRT - Radiation fSRT
fSRT
Primary outcome measures
- radio necrosis or local failure [Time frame: 2 years after treatment]
Secondary outcome measures (7)
- Survival [Time frame: 2 years after treatment]
- symptomatic radio necrosis (RN) or local failure (LF) [Time frame: 2 years after treatment]
- salvage treatment [Time frame: 2 years after treatment]
- distant brain recurrences [Time frame: 2 years after treatment]
- Dose dexamethasone [Time frame: baseline - 2 years after treatment]
- Anti-epileptic drug use [Time frame: baseline - 2 years after treatment]
- Grade 2 or more toxicity (CTCAE v5.0) [Time frame: baseline - 2 years after treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Haaglanden Medisch Centrum — Leidschendam
Publications
- Crouzen JA, Petoukhova AL, Broekman MLD, Fiocco M, Fisscher UJ, Franssen JH, Gadellaa-van Hooijdonk CGM, Kerkhof M, Kiderlen M, Mast ME, van Rij CM, Nandoe Tewarie R, van de Sande MAE, van der Toorn PPG, Vlasman R, Vos MJ, van der Voort van Zyp NCMG, Wiggenraad RGJ, Wiltink LM, Zindler JD. SAFESTEREO: phase II randomized trial to compare stereotactic radiosurgery with fractionated stereotactic rad PMID 36964529
Identifiers
NCT: NCT05346367 · 2021-115LR