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Ion Therapy Patient Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by EBG MedAustron GmbH
Sponsor:
Information provided by (Responsible Party):
EBG MedAustron GmbH
ClinicalTrials.gov Identifier:
NCT03049072
First received: January 13, 2017
Last updated: February 7, 2017
Last verified: February 2017
  Purpose
The purpose of the study is the prospective and standardized data collection of patients treated with ion therapy at MedAustron.

Condition Intervention
Ion Beam Radiation Therapy for Tumor Patients
Radiation: Protons and Carbon Ions

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Prospective Patient Registry for the Evaluation of Efficacy and Safety of Ion Therapy at MedAustron

Further study details as provided by EBG MedAustron GmbH:

Primary Outcome Measures:
  • 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 [ Time Frame: 10 years ]
    Acute/late toxicity according to CTCAEv4.3


Secondary Outcome Measures:
  • EORTC-QLQ-C30 [ Time Frame: Through study completion, at 3, 5, and 10 years ]
    Patient-reported quality of life

  • EORTC-QLQ-BN20 [ Time Frame: Through study completion, at 3, 5, and 10 years ]
    Patient-reported quality of life for brain cancer patients

  • EORTC-QLQ-PR25 [ Time Frame: Through study completion, at 3, 5, and 10 years ]
    Patient-reported quality of life for prostate cancer patients

  • 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


Estimated Enrollment: 800
Study Start Date: January 2017
Estimated Study Completion Date: December 2030
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with ion beam therapy at MedAustron
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03049072

Contacts
Contact: Eugen B Hug, Prof. MD +43 2622 26 100 ext 102 eugen.hug@medaustron.at
Contact: Petra Georg, PhD MD +43 2622 26 100 ext 356 petra.georg@medaustron.at

Locations
Austria
EBG MedAustron GmbH Recruiting
Wiener Neustadt, Niederösterreich, Austria, 2700
Contact: Eugen B Hug, Prof. Dr.    +43 2622 26 100 ext 102    eugen.hug@medaustron.at   
Contact: Petra Georg, PD Dr.    +43 2622 26 100 ext 356    petra.georg@medaustron.at   
Sponsors and Collaborators
EBG MedAustron GmbH
Investigators
Principal Investigator: Eugen B Hug, Prof. MD EBG MedAustron GmbH
  More Information

Responsible Party: EBG MedAustron GmbH
ClinicalTrials.gov Identifier: NCT03049072     History of Changes
Other Study ID Numbers: Register
Study First Received: January 13, 2017
Last Updated: February 7, 2017

ClinicalTrials.gov processed this record on May 25, 2017