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E²-RADIatE: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe (E²-RADIatE)

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: NCT03818503
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Study Description
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Brief Summary:
The primary objective is the collection of real-world data of cancer patients treated with radiotherapy, to support radiotherapy research and to provide evidence of the role of radiation oncology in a multidisciplinary approach. This is an open ended prospective non-interventional non-therapeutic multi-cohort study.

Condition or disease
Cancer

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: E²-RADIatE: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024
Groups and Cohorts
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Group/Cohort
OligoCare
Patients with oligometastatic disease treated with radical radiotherapy
ParticleCare
Patients with cancer treated with particle therapy


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients treated with radiotherapy enrolled in the program [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: 5 years ]
  2. Loco-regional control [ Time Frame: 5 years ]
  3. Distant metastasis free survival [ Time Frame: 5 years ]
  4. Overall survival [ Time Frame: 5 years ]
  5. Incidence of adverse events related to radiotherapy [ Time Frame: 5 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patient with various tumor types planned to be treated with radiation therapy
Criteria

Inclusion Criteria:

  • Pathologically confirmed cancer.
  • Written informed consent for E²-RADIatE according to applicable legal and ethical requirements
  • Planned use of radiotherapy
  • Eligibility of the patient confirmed for at least one cohort confirmed
  • Patients of 12 years and older
Contacts and Locations
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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): NCT03818503


Contacts
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Contact: EORTC HQ +32 2 774 1611 1811@eortc.org

Locations
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Belgium
Onze Lieve Vrouw Ziekenhuis Recruiting
Aalst, Belgium, 9300
Contact: Luc Verbeke         
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Xavier Geets         
Universitair Ziekenhuis Gent Recruiting
Gent, Belgium, 9000
Contact: Yolande Lievens         
Hopital De Jolimont Recruiting
Haine-Saint-Paul, Belgium, 7100
Contact: Yannick Neybuch         
AZ Groeninge Kortrijk - Campus Kennedylaan Recruiting
Kortrijk, Belgium, 8500
Contact: Karin Stellamans         
France
Clinique Pasteur-Toulouse-Atrium Recruiting
Toulouse, France, BP27617
Contact: Igor Latorzeff         
Italy
Istituto Clinico Humanitas Recruiting
Milan, Italy, 20089
Contact: Marta Scorsetti         
Sacro Cuore Hospital Recruiting
Negrar, Italy, 37024
Contact: Filippo Alongi         
Istituti Clinici Scientifici Maugeri Recruiting
Pavia, Italy, 27100
Contact: Giovanni Battista Ivaldi         
Universita Di Torino Recruiting
Torino, Italy, 10126
Contact: Umberto Ricardi         
Netherlands
Radboudumc - Radboud University Medical Center Nijmegen Recruiting
Nijmegen, Netherlands, 6525
Contact: Petra Braam         
Switzerland
Inselspital Recruiting
Bern, Switzerland, 3010
Contact: Hossein Hemmatazad         
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie Recruiting
Geneve, Switzerland, 1211
Contact: Thomas Zilli         
Hopital du Valais - Hopital de Sion Recruiting
Sion, Switzerland, 1951
Contact: Kaouthar Khanfir         
UniversitaetsSpital Zurich Recruiting
Zürich, Switzerland, 8091
Contact: Matthias Guckenberger         
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
More Information
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Additional Information:

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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT03818503    
Other Study ID Numbers: EORTC-1811
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No