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Recruiting

NCT Number: NCT03049072

Ion Therapy Patient Registry

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

Recruiting

Interested in participating?

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protons and Carbon Ions

Radiation

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Piero Fossati, MD MSc

CONTACT

[email protected]

+43 2622 26 100 ext. 408

Yvonne Goy, MD

CONTACT

[email protected]

+43 2622 26 100 ext. 407

Sponsors and collaborators

Lead sponsor

EBG MedAustron GmbH

Industry

Registry information

Official study title

A Prospective Registry Study to Record Clinical Results and Side Effects of Ion Beam Therapy at MedAustron

Acronym: REGI-MA-002015

Important dates

Study start
2016
Primary completion
2031
Study completion
2036
First posted
Feb 9, 2017
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.