Analysis of Outcomes and Adverse Events of Patients Undergoing Radiation Therapy

Recruiting

• Conditions: Radiotherapy; Adverse Effect; Radiotherapy; Complications; Quality of Life
• Interventions: Radiation: Radiotherapy

• Registration Number: NCT05192876
• Lead Sponsor: Daniel Zwahlen

Brief Summary

Analysis of outcomes and adverse events of patients undergoing radiation therapy. Quality control using data base of patient records 2000-2025

Detailed Description

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

Study Timeline

• Study Start: 2000-01-01
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2022-01-01
• Study First Posted: 2022-01-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-17
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Data Base of Patient Records 2000-2025	Radiotherapy	Analysis of outcomes and adverse events

Primary Outcome Measures

Name	Time	Method
Analysis of risk factors influencing outcome after radiation therapy	25 years	Calculation of log-rank tests. If possible, hazard ratios are calculated via Cox regression. Competing risk analysis is conducted as supportive analysis
Overall survival (OS) and progression free survival (PFS) analysis after radiation therapy	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

Secondary Outcome Measures

Name	Time	Method
Number of patients with acute and late adverse events after radiation therapy	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

Trial Locations

Locations (1)

Kantonsspital Winterthur; 🇨🇭 Winterthur, Zurich, Switzerland