Ion Therapy Patient Registry

Conditions

Ion Beam Radiation Therapy for Tumor Patients

Brief summary

The purpose of the study is the prospective and standardized data collection of patients treated with ion therapy at MedAustron.

Detailed description

During and up to 10 years after radiation therapy data regarding tumor control and treatment response as well as acute and late toxicities will be collected at regular time intervals. Additionally quality of life and sociodemographic status will be assessed in all study patients and neurocognitive assessment will be performed in patients undergoing ion radiation of the brain.

Maciej Pelak, Carola Lütgendorf‐Caucig, Birgit Flechl, Ulrike Mock, Petra Mózes et al. (15 authors)

Neuro-Oncology2023-09-01

10.1093/neuonc/noad137.170

P03.06.B Proton irradiation (PT) for benign meningiomas, Grade I clinical experience of the first 100 patients from REGI-MA-002015

Carola Lütgendorf‐Caucig, Eugen B. Hug, Maciej Pelak, Birgit Flechl, Ulrike Mock et al. (10 authors)

Neuro-Oncology2022-09-01

10.1093/neuonc/noac174.110

JS09.6.A Low incidence of radiation-induced brain lesions and stable QoL following proton irradiation for CNS and Skull Base tumors- results from the prospective MedAustron register REGI-MA-002015

Carola Lütgendorf‐Caucig, Birgit Flechl, Lisa Konrath, Maciej Pelak, A. Fraller et al. (10 authors)

Neuro-Oncology2022-09-01

10.1093/neuonc/noac174.028

Interventions

RADIATIONProtons and Carbon Ions

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

Inclusion criteria

* Patients with tumor disease treated with ion beam therapy at MedAustron * Signed informed consent form

Exclusion criteria

* Comorbidities endangering treatment delivery or study compliance

Design outcomes

Primary

Measure	Time frame	Description
Therapy response	10 years	Therapy Response according to RECIST Version 1.1
Overall survival	10 years	—
Progression-free survival	10 years	—
Local progression-free survival	10 years	—
Cause-specific survival	10 years	—
Toxicity according to NCI CTCAE	10 years	Acute/late toxicity according to CTCAEv4.03, June 14,2010

Secondary

Measure	Time frame	Description
EORTC-QLQ-C30	Through study completion, at 3, 5, and 10 years	Patient-reported quality of life
EORTC-QLQ-BN20	Through study completion, at 3, 5, and 10 years	Patient-reported quality of life for brain cancer patients
EORTC-QLQ-PR25	Through study completion, at 3, 5, and 10 years	Patient-reported quality of life for prostate cancer patients
Neurocognitive test battery	Through study completion, at 3, 5, and 10 years	Change in cognition from baseline to endpoint as measured by standardized subtests of test battery

Countries

Austria

Contacts

CONTACTYvonne Goy, MD

yvonne.goy@medaustron.at+43 2622 26 100

CONTACTPiero Fossati, MD MSc

piero.fossati@medaustron.at+43 2622 26 100

PRINCIPAL_INVESTIGATORYvonne Goy, MD

EBG MedAustron GmbH

PRINCIPAL_INVESTIGATORPiero Fossati, MD MSc