Ion Therapy Patient Registry

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03049072

Studienbeginn:
Dezember 2016

Letztes Update:
28.03.2024

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
EBG MedAustron GmbH

Collaborator:
-

Studienleiter

Carola Lütgendorf-Caucig, MD MPH MBA
Principal Investigator
EBG MedAustron GmbH

Kontakt

Carola Lütgendorf-Caucig, MD MPH MBA
Kontakt:
Phone: +43 2622 26 100
Phone (ext.): 402
E-Mail: carola.luetgendorf-caucig@medaustron.at» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

EBG MedAustron GmbH
2700 Wiener Neustadt
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Carola Lütgendorf-Caucig, MD MPH MBA
Phone: +43 2622 26 100
Phone (ext.): 402
E-Mail: carola.luetgendorf-caucig@medaustron.at» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Therapy response (Time Frame - 10 years):
Therapy Response according to RECIST Version 1.1

2. Overall survival (Time Frame - 10 years)

3. Progression-free survival (Time Frame - 10 years)

4. Local progression-free survival (Time Frame - 10 years)

5. Cause-specific survival (Time Frame - 10 years)

6. Toxicity according to NCI CTCAE (Time Frame - 10 years):
Acute/late toxicity according to CTCAEv4.03, June 14,2010

Secondary outcome:

1. EORTC-QLQ-C30 (Time Frame - Through study completion, at 3, 5, and 10 years):
Patient-reported quality of life

2. EORTC-QLQ-BN20 (Time Frame - Through study completion, at 3, 5, and 10 years):
Patient-reported quality of life for brain cancer patients

3. EORTC-QLQ-PR25 (Time Frame - Through study completion, at 3, 5, and 10 years):
Patient-reported quality of life for prostate cancer patients

4. Neurocognitive test battery (Time Frame - Through study completion, at 3, 5, and 10 years):
Change in cognition from baseline to endpoint as measured by standardized subtests of test battery

Geprüfte Regime

Protons and Carbon Ions

Quelle: ClinicalTrials.gov

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