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Ion Therapy Patient Registry (REGI-MA-002015)

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ClinicalTrials.gov Identifier: NCT03049072
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
EBG MedAustron GmbH

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

Condition or disease Intervention/treatment
Ion Beam Radiation Therapy for Tumor Patients 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.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: A Prospective Registry Study to Record Clinical Results and Side Effects of Ion Beam Therapy at MedAustron
Study Start Date : January 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2030

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



Primary Outcome Measures :
  1. Therapy response [ Time Frame: 10 years ]
    Therapy Response according to RECIST Version 1.1

  2. Overall survival [ Time Frame: 10 years ]
  3. Progression-free survival [ Time Frame: 10 years ]
  4. Local progression-free survival [ Time Frame: 10 years ]
  5. Cause-specific survival [ Time Frame: 10 years ]
  6. Toxicity [ Time Frame: 10 years ]
    Acute/late toxicity according to CTCAEv4.03, June 14,2010


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

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

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

  4. 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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: EBG MedAustron GmbH
ClinicalTrials.gov Identifier: NCT03049072     History of Changes
Other Study ID Numbers: Register
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018