NCT03049072

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,800

participants targeted

Target at P75+ for all trials

Timeline
129mo left

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Dec 2016Dec 2036

Study Start

First participant enrolled

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
14.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2031

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2036

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

15 years

First QC Date

January 13, 2017

Last Update Submit

March 19, 2026

Conditions

Ion Beam Radiation Therapy for Tumor Patients

Outcome Measures

Primary Outcomes (6)

  • Therapy response

    Therapy Response according to RECIST Version 1.1

    10 years

  • 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

    Acute/late toxicity according to CTCAEv4.03, June 14,2010

    10 years

Secondary Outcomes (4)

  • EORTC-QLQ-C30

    Through study completion, at 3, 5, and 10 years

  • EORTC-QLQ-BN20

    Through study completion, at 3, 5, and 10 years

  • EORTC-QLQ-PR25

    Through study completion, at 3, 5, and 10 years

  • Neurocognitive test battery

    Through study completion, at 3, 5, and 10 years

Study Arms (1)

Ion beam therapy

All patients treated with ion beam therapy at MedAustron who consent to the participation in the registry.

Radiation: Protons and Carbon Ions

Interventions

Protons and Carbon IonsRADIATION
Ion beam therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with ion beam therapy at MedAustron

You may qualify if:

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

You may not qualify if:

  • Comorbidities endangering treatment delivery or study compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EBG MedAustron GmbH

Wiener Neustadt, Lower Austria, 2700, Austria

RECRUITING

MeSH Terms

Interventions

Protons

Intervention Hierarchy (Ancestors)

Cations, MonovalentCationsIonsElectrolytesInorganic ChemicalsHydrogenElementsGasesNucleonsElementary ParticlesPhysical Phenomena

Study Officials

  • Yvonne Goy, MD

    EBG MedAustron GmbH

    PRINCIPAL INVESTIGATOR

  • Piero Fossati, MD MSc

    EBG MedAustron GmbH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yvonne Goy, MD

CONTACT

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

Piero Fossati, MD MSc

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2017

First Posted

February 9, 2017

Study Start

December 1, 2016

Primary Completion (Estimated)

December 1, 2031

Study Completion (Estimated)

December 1, 2036

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations

AU(1)