Ion Beam Radiation Therapy for Tumor PatientsREGI-MA-002015NCT03049072
Ion Therapy Patient Registry
An observational study of Ion Beam Radiation Therapy for Tumor Patients, run by EBG MedAustron GmbH at 1 site in Austria.
Trial summary
The purpose of the study is the prospective and standardized data collection of patients treated with ion therapy at MedAustron. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ion Beam Radiation Therapy for Tumor Patients
- What is being tested?
- Protons and Carbon Ions
- Type of treatment
- Surgery or procedure
- How many people
- 2,800 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2016to Dec 2036
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated with ion beam therapy at MedAustron
Who may be able to join
- Patients with tumor disease treated with ion beam therapy at MedAustron
- Signed informed consent form
Who cannot join
- Comorbidities endangering treatment delivery or study compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
EBG MedAustron GmbH
Wiener Neustadt, Lower Austria, 2700
Yvonne Goy, MD, +43 2622 26 100 ext. 407, yvonne.goy@medaustron.at
Piero Fossati, MD MSc, +43 2622 26 100 ext. 408, piero.fossati@medaustron.at
About this study
Official title: A Prospective Registry Study to Record Clinical Results and Side Effects of Ion Beam Therapy at MedAustron
The purpose of the study is the prospective and standardized data collection of patients treated with ion therapy at MedAustron.
Read the 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.
- Being tested
- Protons and Carbon Ions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protons and Carbon IonsRadiation
| Study group | Role | What they receive |
|---|---|---|
| Ion beam therapy | All patients treated with ion beam therapy at MedAustron who consent to the participation in the registry. Receives: Radiation: Protons and Carbon Ions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapy response
Therapy Response according to RECIST Version 1.1
Measured: 10 years
Overall survival
Measured: 10 years
Progression-free survival
Measured: 10 years
Local progression-free survival
Measured: 10 years
Cause-specific survival
Measured: 10 years
Toxicity according to NCI CTCAE
Acute/late toxicity according to CTCAEv4.03, June 14,2010
Measured: 10 years
Secondary outcomes (4)
EORTC-QLQ-C30
Patient-reported quality of life
Measured: Through study completion, at 3, 5, and 10 years
EORTC-QLQ-BN20
Patient-reported quality of life for brain cancer patients
Measured: Through study completion, at 3, 5, and 10 years
EORTC-QLQ-PR25
Patient-reported quality of life for prostate cancer patients
Measured: Through study completion, at 3, 5, and 10 years
Neurocognitive test battery
Change in cognition from baseline to endpoint as measured by standardized subtests of test battery
Measured: Through study completion, at 3, 5, and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startDec 2016
- Primary completionDec 2031 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ion Beam Radiation Therapy for Tumor PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,800 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- EBG MedAustron GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yvonne Goy, MD, Principal investigator, EBG MedAustron GmbHPiero Fossati, MD MSc, Principal investigator, EBG MedAustron GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049072
- Sponsor's protocol ID
- REGI-MA-002015
- Acronym
- REGI-MA-002015
- Status last verified
- Mar 2026
- First submitted
- 13 Jan 2017
- Last updated
- 23 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry Study to Record Clinical Results and Side Effects of Ion Beam Therapy at MedAustron
- ClinicalTrials.gov ID
- NCT03049072
- Acronym / sponsor ID
- REGI-MA-002015 / REGI-MA-002015
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- EBG MedAustron GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ion beam therapy | – | Radiation: Protons and Carbon IonsAll patients treated with ion beam therapy at MedAustron who consent to the participation in the registry. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with ion beam therapy at MedAustron
Key inclusion criteria (2 listed)
- Patients with tumor disease treated with ion beam therapy at MedAustron
- Signed informed consent form
Key exclusion criteria (1 listed)
- Comorbidities endangering treatment delivery or study compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protons and Carbon Ions | Radiation | Ion beam therapy |
Primary outcome
Therapy response
Time frame: 10 years
Therapy Response according to RECIST Version 1.1
Overall survival
Time frame: 10 years
Progression-free survival
Time frame: 10 years
Local progression-free survival
Time frame: 10 years
Cause-specific survival
Time frame: 10 years
Toxicity according to NCI CTCAE
Time frame: 10 years
Acute/late toxicity according to CTCAEv4.03, June 14,2010
4 secondary outcomes
EORTC-QLQ-C30
Time frame: Through study completion, at 3, 5, and 10 years
EORTC-QLQ-BN20
Time frame: Through study completion, at 3, 5, and 10 years
EORTC-QLQ-PR25
Time frame: Through study completion, at 3, 5, and 10 years
Neurocognitive test battery
Time frame: Through study completion, at 3, 5, and 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yvonne Goy, MD principal investigator
EBG MedAustron GmbH
Piero Fossati, MD MSc principal investigator
EBG MedAustron GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ion Beam Radiation Therapy for Tumor Patients, run by EBG MedAustron GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yvonne Goy, MD (+43 2622 26 100 ext. 407, yvonne.goy@medaustron.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapy response (time frame: 10 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.