Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Medical Center Groningen | OTHER |
| HollandPTC | INDUSTRY |
| Erasmus Medical Center | OTHER |
| Leiden University Medical Center |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProTRAIT | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive failure at 5 years | 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 | 5 years after radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| HVLT- delayed recall decline at 5 years | HVLT- delayed recall decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data | 5 years after radiotherapy |
| HVLT total recall decline at 5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
All neuro-oncological patients treated with proton therapy at one of the three proton centers in the Netherlands
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danielle Eekers | Contact | +31884455600 | danielle.eekers@maastro.nl | |
| Hiske van der Weide | Contact | +31503612711 | h.l.van.der.weide@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| Danielle Eekers | Maastro Clinic, The Netherlands | Principal Investigator |
| Danielle Eekers | Maastro Clinic, The Netherlands | Study Chair |
| Hiske van der Weide |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht Radiation Oncology | Recruiting | Maastricht | Limburg | 6202 AZ | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
| Medical Center Haaglanden | OTHER |
| Maastro Clinic, The Netherlands | OTHER |
Not provided
Not provided
Not provided
HVLT total recall decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data
| 5 years after radiotherapy |
| TMT a decline at 5 years | TMT a decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data | 5 years after radiotherapy |
| TMT b decline at 5 years | TMT b decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data | 5 years after radiotherapy |
| COWA total decline at 5 years | COWA total decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data | 5 years after radiotherapy |
| UMC Groningen |
| Principal Investigator |
| M Kramer | UMC Groningen | Principal Investigator |
| Yvonne Klaver | HollandPTC | Principal Investigator |
| M Kroesen | HollandPTC | Principal Investigator |
| A Mendez Romero | Erasmus Medical Center | Principal Investigator |
| J Jaspers | Erasmus Medical Center | Principal Investigator |
| I Coremans | Leiden University Medical Center | Principal Investigator |
| Jaap Zindler | Medical Center Haaglanden | Principal Investigator |
| Inge Compter | Maastro Clinic, The Netherlands | Principal Investigator |
| Holland PTC | Recruiting | Delft | South Holland | 2629 JH | Netherlands |
|
| Universitair Medisch Centrum Groningen | Recruiting | Groningen | 9713 WS | Netherlands |
|
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D004806 | Ependymoma |
| D018303 | Ganglioglioma |
| D009837 | Oligodendroglioma |
| D020339 | Optic Nerve Glioma |
| D008579 | Meningioma |
| D018317 | Nerve Sheath Neoplasms |
| D000236 | Adenoma |
| D003397 | Craniopharyngioma |
| D006393 | Hemangiopericytoma |
| D018237 | Germinoma |
| D009442 | Neurilemmoma |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D019574 | Optic Nerve Neoplasms |
| D003390 | Cranial Nerve Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D010524 | Peripheral Nervous System Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D009901 | Optic Nerve Diseases |
| D005128 | Eye Diseases |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D018358 | Neuroendocrine Tumors |
| D009463 | Neuroma |
Not provided
Not provided