Analysis of Outcomes and Adverse Events of Patients Undergoing Radiation Therapy

Sponsor
Daniel Zwahlen (Other)
Overall Status
Recruiting
CT.gov ID
NCT05192876
Collaborator
(none)
25,000
1
312
80.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
25000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Analysis of Outcomes and Adverse Events of Patients Undergoing Radiation Therapy. Quality Control Using Data Base of Patient Records 2000-2025
Actual Study Start Date :
Jan 1, 2000
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Data Base of Patient Records 2000-2025

Analysis of outcomes and adverse events

Radiation: Radiotherapy
Outcomes and adverse events using radiation therapy

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

Secondary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 105 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kantonsspital Winterthur Winterthur Zurich Switzerland 8401

Sponsors and Collaborators

  • Daniel Zwahlen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daniel Zwahlen, Prof. Dr. med. Daniel R. Zwahlen, Kantonsspital Winterthur KSW
ClinicalTrials.gov Identifier:
NCT05192876
Other Study ID Numbers:
  • BASEC-Nr. 2020-02112
First Posted:
Jan 14, 2022
Last Update Posted:
Jan 14, 2022
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 14, 2022