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

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

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Radiotherapy; Complications; Radiotherapy; Adverse Effect
• Intervention / Treatment: Radiation: Radiotherapy

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 Type: Observational
• Enrollment (Estimated): 25000

Contacts and Locations

• Study Contact: Name: Daniel R Zwahlen, MD, MBA; Phone Number: +41522662645; Email: daniel.zwahlen@ksw.ch
• Study Contact Backup: Name: Romy Frey; Phone Number: +41522662645; Email: romy.frey@ksw.ch

Study Locations

• Switzerland
  • Zurich
    • Winterthur, Zurich, Switzerland, 8401
      • Recruiting
      • Kantonsspital Winterthur
      • Contact: Daniel R Zwahlen, MD, MBA; Phone Number: +4152662645; Email: daniel.zwahlen@ksw.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 105 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients who are being treated with radiotherapy at the Department of Radiation Oncology at the Winterthur Cantonal Hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Data Base of Patient Records 2000-2025; Analysis of outcomes and adverse events	Radiation: Radiotherapy; Outcomes and adverse events using radiation therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with acute and late adverse events after radiation therapy	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	25 years

Collaborators and Investigators

• Sponsor: Daniel Zwahlen
• Investigators: Principal Investigator: Daniel Zwahlen, MD, MBA, Kantonsspital Winterthur KSW

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2000
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: January 1, 2022
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 17, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: BASEC-Nr. 2020-02112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No