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Recruiting NCT03049072

Ion Therapy Patient Registry

Observational Ion Beam Radiation Therapy for Tumor Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Protons and Carbon Ions.
Who it may be relevant to
Registry conditions: Ion Beam Radiation Therapy for Tumor Patients. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Radiation Protons and Carbon Ions

Primary outcome measures

  • Therapy response [Time frame: 10 years]
  • 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]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Austria · 1 center
  • EBG MedAustron GmbH — Wiener Neustadt

Identifiers

NCT: NCT03049072 · REGI-MA-002015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗