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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

Tracking Information
First Submitted Date January 17, 2019
First Posted Date January 28, 2019
Last Update Posted Date November 13, 2019
Actual Study Start Date June 24, 2019
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 24, 2019)		 Number of patients treated with radiotherapy enrolled in the program [ Time Frame: 5 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 24, 2019)
  • Disease free survival [ Time Frame: 5 years ]
  • Loco-regional control [ Time Frame: 5 years ]
  • Distant metastasis free survival [ Time Frame: 5 years ]
  • Overall survival [ Time Frame: 5 years ]
  • Incidence of adverse events related to radiotherapy [ Time Frame: 5 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title E²-RADIatE: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe
Official Title E²-RADIatE: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient with various tumor types planned to be treated with radiation therapy
Condition Cancer
Intervention Not Provided
Study Groups/Cohorts
  • OligoCare
    Patients with oligometastatic disease treated with radical radiotherapy
  • ParticleCare
    Patients with cancer treated with particle therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 24, 2019)		 1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 30, 2024
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: EORTC HQ +32 2 774 1611 1811@eortc.org
Listed Location Countries Belgium,   France,   Italy,   Netherlands,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03818503
Other Study ID Numbers EORTC-1811
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Collaborators Not Provided
Investigators Not Provided
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date November 2019