Ion Therapy Patient Registry (REGI-MA-002015)

March 27, 2024 updated by: EBG MedAustron GmbH

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
    • Niederösterreich
      • Wiener Neustadt, Niederösterreich, Austria, 2700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated with ion beam therapy at MedAustron

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EORTC-QLQ-C30
Time Frame: Through study completion, at 3, 5, and 10 years
Patient-reported quality of life
Through study completion, at 3, 5, and 10 years
EORTC-QLQ-BN20
Time Frame: Through study completion, at 3, 5, and 10 years
Patient-reported quality of life for brain cancer patients
Through study completion, at 3, 5, and 10 years
EORTC-QLQ-PR25
Time Frame: Through study completion, at 3, 5, and 10 years
Patient-reported quality of life for prostate cancer patients
Through study completion, at 3, 5, and 10 years
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
Through study completion, at 3, 5, and 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EBG MedAustron GmbH

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Estimated)

December 1, 2031

Study Completion (Estimated)

December 1, 2036

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

February 7, 2017

First Posted (Estimated)

February 9, 2017

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • REGI-MA-002015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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