Radiotherapy; Adverse EffectNCT05192876
Analysis of Outcomes and Adverse Events of Patients Undergoing Radiation Therapy
An observational study of Radiotherapy; Adverse Effect and Radiotherapy; Complications, run by Daniel Zwahlen at 1 site in Switzerland.
Trial summary
Analysis of outcomes and adverse events of patients undergoing radiation therapy. Quality control using data base of patient records 2000-2025 Read more about this study
- Who is it for?
- Ages 16 to 105 years
- Conditions the study is for
- Radiotherapy; Adverse Effect, Radiotherapy; Complications, Quality of Life
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 25,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2000to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 105 years
- All sexes
- Child, Adult, Older adult
Study population: Patients who are being treated with radiotherapy at the Department of Radiation Oncology at the Winterthur Cantonal Hospital
Who may be able to join
- Patients who are being treated with radiotherapy at the Department of Radiation Oncology at the Winterthur Cantonal Hospital
Who cannot join
- No radiotherapy at the Department of Radiation Oncology at the Winterthur Cantonal Hospital <16 years,> 105 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401
Daniel R Zwahlen, MD, MBA, +4152662645, daniel.zwahlen@ksw.ch
About this study
Official title: 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
Read the 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
- Being tested
- Radiotherapy
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Outcomes and adverse events using radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Data Base of Patient Records 2000-2025 | Analysis of outcomes and adverse events Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 25 years
Secondary outcomes (1)
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
Measured: 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start1 Jan 2000
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiotherapy; Adverse EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniel Zwahlen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Zwahlen, Kantonsspital Winterthur KSW
- Investigators
- Daniel Zwahlen, MD, MBA, Principal investigator, Kantonsspital Winterthur KSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192876
- Sponsor's protocol ID
- BASEC-Nr. 2020-02112
- Status last verified
- May 2025
- First submitted
- 4 Aug 2021
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Windisch P, Becker I, Tang H, Schroder C, Buchali A, Aebersold DM, Zwahlen DR, Forster R, Shelan M. Converting between the International Prostate Symptom Score (IPSS) and the Expanded Prostate Cancer Index Composite (EPIC) urinary subscales: modeling and external validation. BMC Urol. 2024 Feb 3;24(1):28. doi: 10.1186/s12894-024-01421-y.
PubMed 38310268
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Outcomes and Adverse Events of Patients Undergoing Radiation Therapy. Quality Control Using Data Base of Patient Records 2000-2025
- ClinicalTrials.gov ID
- NCT05192876
- Acronym / sponsor ID
- BASEC-Nr. 2020-02112
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Daniel ZwahlenUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Data Base of Patient Records 2000-2025 | – | Radiation: RadiotherapyAnalysis of outcomes and adverse events |
Who may qualify
- Ages
- 16 to 105 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are being treated with radiotherapy at the Department of Radiation Oncology at the Winterthur Cantonal Hospital
Key inclusion criteria (1 listed)
- Patients who are being treated with radiotherapy at the Department of Radiation Oncology at the Winterthur Cantonal Hospital
Key exclusion criteria (1 listed)
- No radiotherapy at the Department of Radiation Oncology at the Winterthur Cantonal Hospital <16 years,> 105 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyOutcomes and adverse events using radiation therapy | Radiation | Data Base of Patient Records 2000-2025 |
Primary outcome
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
1 secondary outcome
Number of patients with acute and late adverse events after radiation therapy
Time frame: 25 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Derived from this study: PubMed 38310268Windisch P, Becker I, Tang H, Schroder C, Buchali A, Aebersold DM, Zwahlen DR, Forster R, Shelan M. Converting between the International Prostate Symptom Score (IPSS) and the Expanded Prostate Cancer Index Composite (EPIC) urinary subscales: modeling and external validation. BMC Urol. 2024 Feb 3;24(1):28. doi: 10.1186/s12894-024-01421-y.
- Individual participant dataSharing planned: No
Related trials for Radiotherapy; Adverse Effect
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
Not yet recruitingPhase 2
The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity
Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy
Not yet recruitingObservational study
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Heart Failure, Coronary Artery Disease
Not yet recruiting
Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)
Cardiotoxicity, Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Zwahlen, MD, MBA principal investigator
Kantonsspital Winterthur KSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiotherapy; Adverse Effect and Radiotherapy; Complications, run by Daniel Zwahlen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel R Zwahlen, MD, MBA (+41522662645, daniel.zwahlen@ksw.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) and progression free survival (PFS) analysis after radiation therapy (time frame: 25 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05192876, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.