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Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

stereotactic radiotherapy in 1 or 3 fractions of 8 Gy up to 15-24 Gy

hypo fractionated stereotactic radiotherapy in 5 fractions of 7 Gy up to 35 Gy. Brain stem metastases 5 fractions of 6 Gy up to 30 Gy

fSRT

Jaap D Zindler, MD, PhD

Mirjam Mast, PhD

Jaap Zindler, Dr

Ursula Fisscher, PhD

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.

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.

Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases

Incidence of either radio necrosis or local failure according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM).

median survival with Kaplan Meyer analysis

incidence of RN or LF within 2 years after SRT

incidence of salvage treatment within 2 years after SRT

incidence of distant brain recurrences within 2 years after SRT

incidence of Grade 2 or more toxicity according to CTCAE version 5.0 within 2 years after SRT

Haaglanden Medical Centre

Principal Investigator, MD, PhD, radiation oncologist

Each cerebral metastasis (hemorrhagic or otherwise) will be treated by radiation

For each metastasis, dose of 30 Gy in 3 fractions at 10 Gy / fraction over 7 days

FSRT Stereotactic radiation therapy

Julien GEFRELOT, MD

Dinu STEFAN, MD

Victor PERNIN, MD

Julien GEFFRELOT, MD

Selima SELLAMI, MD

This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases	NCT05346367	Brain Metastase...	SRT fSRT	18 Years -	Haaglanden Medical Centre
Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases	NCT05346367	Brain Metastase...	SRT fSRT	18 Years -	Haaglanden Medical Centre
Stereotactic Radiotherapy for Cerebral Metastases With Recent Hemorrhagic Signal	NCT03696680	Hemorrhagic Bra...	FSRT Stereotact...	18 Years -	Centre Francois Baclesse
Stereotactic Radiotherapy for Cerebral Metastases With Recent Hemorrhagic Signal	NCT03696680	Hemorrhagic Bra...	FSRT Stereotact...	18 Years -	Centre Francois Baclesse

Spots Global Cancer Trial Database for fsrt

Every month we try and update this database with for fsrt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fsrt

Every month we try and update this database with for fsrt cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fsrt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.