Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401, Switzerland
Location status: Recruiting
Recruiting
NCT Number: NCT05192876
Analysis of Outcomes and Adverse Events of Patients Undergoing Radiation Therapy
Analysis of outcomes and adverse events of patients undergoing radiation therapy. Quality control using data base of patient records 2000-2025
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
16 year–105 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
What are the findings of the systematic recording and analysis of the outcomes and adverse events of radiotherapy, and how do these findings improve radiotherapy for future patients?
The goals of the systematic collection and analysis of patient-related personal data include:
- Quality assurance and showing where the quality can be improved
- Recording the outcomes and side effect profile of radiotherapy and adapting to prevent serious side effects in the future
- Presentation and publication as part of the clinical research program at the Institute for Radio-Oncology of the Winterthur Cantonal Hospital
Who can participate
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients who are being treated with radiotherapy at the Department of Radiation Oncology at the Winterthur Cantonal Hospital
Exclusion criteria
- No radiotherapy at the Department of Radiation Oncology at the Winterthur Cantonal Hospital <16 years,> 105 years
Treatment and study plan
Radiotherapy
RadiationOutcomes and adverse events using radiation therapy
Primary outcomes
-
Overall survival (OS) and progression free survival (PFS) analysis after radiation therapy
Time frame: 25 years
Calculation of Overall survival (OS) and progression free survival (PFS). Time-to-event endpoints are summarized as the median and corresponding 95% confidence interval using Kaplan-Meier method
-
Analysis of risk factors influencing outcome after radiation therapy
Time frame: 25 years
Calculation of log-rank tests. If possible, hazard ratios are calculated via Cox regression. Competing risk analysis is conducted as supportive analysis
Secondary outcomes
-
Number of patients with acute and late adverse events after radiation therapy
Time frame: 25 years
Predefined toxicity events are described by type, grade, frequency, and percentage across all time points. Fisher's exact tests are used for comparison (base line and defined time points). Quality of life symptom and function scales are used. Two-tailed tests with a significance level of 0.05 are used for all analyses. Adjustments for multiple testing may be used. Some of the analyses are exploratory and hypothesis generating
Study contacts
Contact information is provided by the study sponsor or research team.
Daniel R Zwahlen, MD, MBA
CONTACT
Romy Frey
CONTACT
Sponsors and collaborators
Lead sponsor
Daniel Zwahlen
Other
Registry information
Official study title
Analysis of Outcomes and Adverse Events of Patients Undergoing Radiation Therapy. Quality Control Using Data Base of Patient Records 2000-2025
Important dates
- Study start
- 2000
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Jan 14, 2022
- Registry last updated
- May 21, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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