Analysis of Outcomes and Adverse Events of Patients Undergoing Radiation Therapy

Overview

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

Full Title of Study: “Analysis of Outcomes and Adverse Events of Patients Undergoing Radiation Therapy. Quality Control Using Data Base of Patient Records 2000-2025”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 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

Interventions

  • Radiation: Radiotherapy
    • Outcomes and adverse events using radiation therapy

Arms, Groups and Cohorts

  • Data Base of Patient Records 2000-2025
    • Analysis of outcomes and adverse events

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 105 Years

Investigator Details

  • Lead Sponsor
    • Daniel Zwahlen
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Daniel Zwahlen, Prof. Dr. med. Daniel R. Zwahlen – Kantonsspital Winterthur KSW
  • Overall Official(s)
    • Daniel Zwahlen, MD, MBA, Principal Investigator, Kantonsspital Winterthur KSW
  • Overall Contact(s)
    • Daniel R Zwahlen, MD, MBA, +41522662645, daniel.zwahlen@ksw.ch

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