Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology

Adenoma Clinical Trial

Official title:

Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04648462
• Other study ID #: ProTRAIT-neuro
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: January 1, 2035

Study information

• Verified date: November 2023
• Source: Maastricht Radiation Oncology
• Contact: Danielle Eekers
• Phone: +31884455600
• Email: danielle.eekers[@]maastro.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: January 1, 2035
• Est. primary completion date: January 1, 2030
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Astrocytoma
• Craniopharyngioma
• Ependymoma
• Ganglioglioma
• Germinoma
• Hemangiopericytoma
• Meningioma
• Nerve Sheath Neoplasms
• Neurilemmoma
• Oligodendroglioma
• Optic Nerve Glioma
• Solitary Fibrous Tumors

Intervention

Other:
• ProTRAIT
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.

Locations

Country	Name	City	State
Netherlands	Holland PTC	Delft	Zuid-Holland
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Maastricht Radiation Oncology	Maastricht	Limburg

Sponsors (7)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology	Erasmus Medical Center, HollandPTC, Leiden University Medical Center, Maastro Clinic, The Netherlands, Medical Center Haaglanden, University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	HVLT total recall decline at 5 years	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
Secondary	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
Secondary	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
Secondary	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