- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02500173
Analysis of Effects and Side Effects in Patients Undergoing Radiation Therapy
March 7, 2021 updated by: Kantonsspital Graubuenden
Analysis of Effects and Side Effects in Patients Undergoing Radiation Therapy - Quality Control Using Clinical Database
To collect and analyze effects and side effects in patients undergoing radiotherapy.
This study investigates how analysis of effects and side effects will influence outcome of patients. These retrospectively collected data allow to adapt and improve radiotherapy treatment regimens .
Study Overview
Detailed Description
Effects and side effects in patients undergoing radiotherapy will be collected over the next five years (2015-2020).
It is planned to include 600 to 650 new patients referred for radiotherapy per calender year.
It is estimated that 3000 patients will be included at the end of the study after five years.
Patient Information on diseae and treatment will be collected and analyzed.
Common statistical algorithms will be performed for outcome analysis.
Study Type
Observational
Enrollment (Actual)
1800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Chur, Switzerland, 7000
- Kantonsspital Graubuenden, Department of Radiaton Oncology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 105 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing radiotherapy at the Kantonsspital Graubuenden
Description
Inclusion Criteria:
- Patients undergoing radiotherapy at the Kantonsspital Graubuenden
Exclusion Criteria:
- No radiotherapy at Kantonsspital Graubuenden
- Age: < 20 years, > 105 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Side effects in patients undergoing radiotherapy (CTCAE v4.03)
Time Frame: 5 Years
|
acute and late side effects according to CTCAE
|
5 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Daniel R Zwahlen, MD MBA, Kantonsspital Winterthur, Department of Radiation Oncology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2015
Primary Completion (Actual)
October 21, 2020
Study Completion (Actual)
October 21, 2020
Study Registration Dates
First Submitted
June 18, 2015
First Submitted That Met QC Criteria
July 15, 2015
First Posted (Estimate)
July 16, 2015
Study Record Updates
Last Update Posted (Actual)
March 9, 2021
Last Update Submitted That Met QC Criteria
March 7, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KEK-ZH-Nr.2015-0221
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.