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Analysis of Effects and Side Effects in Patients Undergoing Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02500173
Recruitment Status : Recruiting
First Posted : July 16, 2015
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Kantonsspital Graubuenden

Brief Summary:

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 .


Condition or disease Intervention/treatment
Cancer Radiation: Radiation

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.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Analysis of Effects and Side Effects in Patients Undergoing Radiation Therapy - Quality Control Using Clinical Database
Study Start Date : June 2015
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Intervention Details:
  • Radiation: Radiation
    Radiation therapy


Primary Outcome Measures :
  1. Side effects in patients undergoing radiotherapy (CTCAE v4.03) [ Time Frame: 5 Years ]
    acute and late side effects according to CTCAE



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing radiotherapy at the Kantonsspital Graubuenden
Criteria

Inclusion Criteria:

  • Patients undergoing radiotherapy at the Kantonsspital Graubuenden

Exclusion Criteria:

  • No radiotherapy at Kantonsspital Graubuenden
  • Age: < 20 years, > 105 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500173


Contacts
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Contact: Daniel R Zwahlen, MD MBA +41812566495 daniel.zwahlen@ksgr.ch
Contact: Christoph Oehler, MD MBA +412566495 christoph.oehler@ksgr.ch

Locations
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Switzerland
Kantonsspital Graubuenden, Department of Radiaton Oncology Recruiting
Chur, Switzerland, 7000
Contact: Daniel R Zwahlen, MD MBA    +41812566495    daniel.zwahlen@ksgr.ch   
Contact: Christoph Oehler, MD MBA    +41812566495    christoph.oehler@ksgr.ch   
Sponsors and Collaborators
Kantonsspital Graubuenden
Investigators
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Study Chair: Daniel R Zwahlen, MD MBA Kantonsspital Graubuenden, Department of Radiation Oncology
Additional Information:
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Responsible Party: Kantonsspital Graubuenden
ClinicalTrials.gov Identifier: NCT02500173    
Other Study ID Numbers: KEK-ZH-Nr.2015-0221
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kantonsspital Graubuenden:
radiotherapy
side effects