Ion Therapy Patient Registry

Ion Beam Radiation Therapy for Tumor Patients Clinical Trial

— REGI-MA-002015  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03049072
• Other study ID #: REGI-MA-002015
• Status: Recruiting
• Start date: December 2016
• Est. completion date: December 2036

Study information

• Verified date: March 2024
• Source: EBG MedAustron GmbH
• Contact: Carola Lütgendorf-Caucig, MD MPH MBA
• Phone: +43 2622 26 100
• Email: carola.luetgendorf-caucig[@]medaustron.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2036
• Est. primary completion date: December 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Ion Beam Radiation Therapy for Tumor Patients

Intervention

Radiation:
• Protons and Carbon Ions

Locations

Country	Name	City	State
Austria	EBG MedAustron GmbH	Wiener Neustadt	Niederösterreich

Sponsors (1)

Lead Sponsor	Collaborator
EBG MedAustron GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapy response	Therapy Response according to RECIST Version 1.1	10 years
Primary	Overall survival		10 years
Primary	Progression-free survival		10 years
Primary	Local progression-free survival		10 years
Primary	Cause-specific survival		10 years
Primary	Toxicity according to NCI CTCAE	Acute/late toxicity according to CTCAEv4.03, June 14,2010	10 years
Secondary	EORTC-QLQ-C30	Patient-reported quality of life	Through study completion, at 3, 5, and 10 years
Secondary	EORTC-QLQ-BN20	Patient-reported quality of life for brain cancer patients	Through study completion, at 3, 5, and 10 years
Secondary	EORTC-QLQ-PR25	Patient-reported quality of life for prostate cancer patients	Through study completion, at 3, 5, and 10 years
Secondary	Neurocognitive test battery	Change in cognition from baseline to endpoint as measured by standardized subtests of test battery	Through study completion, at 3, 5, and 10 years