A Prospective Registry Study to Record Clinical Results and Side Effects of Ion Beam Therapy at MedAustron
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- EBG MedAustron GmbH
- Enrollment
- 2,800
- Locations
- 1
- Primary Endpoint
- Therapy response
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Therapy response
Time Frame: 10 years
Therapy Response according to RECIST Version 1.1
Overall survival
Time Frame: 10 years
Local progression-free survival
Time Frame: 10 years
Toxicity according to NCI CTCAE
Time Frame: 10 years
Acute/late toxicity according to CTCAEv4.03, June 14,2010
Progression-free survival
Time Frame: 10 years
Cause-specific survival
Time Frame: 10 years
Secondary Outcomes
- EORTC-QLQ-PR25(Through study completion, at 3, 5, and 10 years)
- EORTC-QLQ-BN20(Through study completion, at 3, 5, and 10 years)
- EORTC-QLQ-C30(Through study completion, at 3, 5, and 10 years)
- Neurocognitive test battery(Through study completion, at 3, 5, and 10 years)