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

Status

Terminated

Conditions

Intervention / Treatment

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

  • Switzerland
      • 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

Kantonsspital Graubuenden

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.

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