Analysis of Outcomes and Adverse Events of Patients Undergoing Radiation Therapy

Quality of Life Clinical Trial

Official title:

Analysis of Outcomes and Adverse Events of Patients Undergoing Radiation Therapy. Quality Control Using Data Base of Patient Records 2000-2025

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05192876
• Other study ID #: BASEC-Nr. 2020-02112
• Status: Recruiting
• Start date: January 1, 2000
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Kantonsspital Winterthur KSW
• Contact: Daniel R Zwahlen, MD, MBA
• Phone: +41522662645
• Email: daniel.zwahlen[@]ksw.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 16 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life
• Radiotherapy; Complications

Intervention

Radiation:
• Radiotherapy
Outcomes and adverse events using radiation therapy

Locations

Country	Name	City	State
Switzerland	Kantonsspital Winterthur	Winterthur	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Daniel Zwahlen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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