Adenoma, Astrocytoma, Craniopharyngioma, Ependymoma, Ganglioglioma, Germinoma, Hemangiopericytoma, Meningioma, Nerve Sheath Neoplasms, Neurilemmoma, Oligodendroglioma, Optic Nerve Glioma
Conditions
Brief summary
The first proton therapy treatments in the Netherlands have taken place in 2018. Due to the physical properties of protons, proton therapy has tremendous potential to reduce the radiation dose to the healthy, tumour-surrounding tissues. In turn, this leads to less radiation-induced complications, and a decrease in the formation of secondary tumours. The Netherlands has spearheaded the development of the model-based approach (MBA) for the selection of patients for proton therapy when applied to prevent radiation-induced complications. In MBA, a pre-treatment in-silico planning study is done, comparing proton and photon treatment plans in each individual patient, to determine (1) whether there is a significant difference in dose in the relevant organs at risk (ΔDose), and (2) whether this dose difference translates into an expected clinical benefit in terms of NormalTissue Complication Probabilities (ΔNTCP). To translate ΔDose into ΔNTCP, NTCP-models are used, which are prediction models describing the relation between dose parameters and the likelihood of radiation-induced complications. The Dutch Society for Radiotherapy and Oncology (NVRO) setup the selection criteria for proton therapy in 2015, taking into account toxicity and NTCP. However, NTCP-models can be affected by changes in the irradiation technique. Therefore, it is paramount to continuously update and validate these NTCP-models in subsequent patient cohorts treated with new techniques. In ProTRAIT, a Findable, Accessible, Interoperable and Reusable (FAIR)data infrastructure for both clinical and 3D image and 3D dose information has been developed and deployed for proton therapy in the Netherlands. It allows for a prospective, standardized, multi-centric data from all Dutch proton and a representative group of photon therapy patients.
Interventions
OTHERProTRAIT
The participants are seen at the outpatient clinic by a physician, physician assistant or trial nurse at standard follow-up times at 2.5, 5, 7.5 and 10 years after radiotherapy.
Sponsors
University Medical Center Groningen
HollandPTC
Erasmus Medical Center
Leiden University Medical Center
Medical Center Haaglanden
Maastro Clinic, The Netherlands
Maastricht Radiation Oncology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. All brain tumors with a favorable prognosis (median survival \> 10 year) 2. Age ≥ 18 years 3. ECOG performance status 0 - 1 / Karnofsky performance status 80 - 100 4. No - minimal neurocognitive impairment 5. Dosimetrical gain of protontherapy relative to photontherapy (≥5% on supratentorial brain dose or hippocampi) 6. Informed consent
Exclusion criteria
1. Not eligible for chemotherapy 2. Eligible for stereotactic radiotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurocognitive failure at 5 years | 5 years after radiotherapy | Time to neurocognitive failure, defined as the time from last radiotherapeutic treatment to the first instance of a measured HVLT-dr of -1.5Z based on the normal data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HVLT- delayed recall decline at 5 years | 5 years after radiotherapy | HVLT- delayed recall decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data |
| HVLT total recall decline at 5 years | 5 years after radiotherapy | HVLT total recall decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data |
| TMT a decline at 5 years | 5 years after radiotherapy | TMT a decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data |
| TMT b decline at 5 years | 5 years after radiotherapy | TMT b decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data |
| COWA total decline at 5 years | 5 years after radiotherapy | COWA total decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data |
Countries
Netherlands
Contacts
Primary ContactDanielle Eekers
Backup ContactHiske van der Weide
Outcome results
None listed