Ion Therapy Patient Registry

Recruiting

• Conditions: Ion Beam Radiation Therapy for Tumor Patients
• Interventions: Radiation: Protons and Carbon Ions

• Registration Number: NCT03049072
• Lead Sponsor: EBG MedAustron GmbH

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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11
• Primary Completion: 2031-12
• Study Completion: 2036-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ion beam therapy	Protons and Carbon Ions	All patients treated with ion beam therapy at MedAustron who consent to the participation in the registry.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
EORTC-QLQ-PR25	Through study completion, at 3, 5, and 10 years	Patient-reported quality of life for prostate cancer patients
EORTC-QLQ-BN20	Through study completion, at 3, 5, and 10 years	Patient-reported quality of life for brain cancer patients
EORTC-QLQ-C30	Through study completion, at 3, 5, and 10 years	Patient-reported quality of life
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

Trial Locations

Locations (1)

EBG MedAustron GmbH; 🇦🇹 Wiener Neustadt, Niederösterreich, Austria