CancerE²-RADIatENCT03818503
E²-RADIatE: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe
An observational study of Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 77 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cancer
- How many people
- 2,000 participants
- Where
- 77 sitesin 14 countries
- Study dates
- 24 Jun 2019to 30 Apr 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patient with various tumor types planned to be treated with radiation therapy
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
77 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
77 sites in 14 countries
Italy16 sites, 13 recruiting
- Recruiting
Ente Ecclesiastico Ospedale Generale Regionale "F. Miulli"
Acquaviva delle Fonti, IT 70021
- Suspended
USL Toscana South East, Ospedale S. Donato
Arezzo, IT 52100
- Recruiting
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, 25123
- Recruiting
Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi
Florence, IT 50134
- Recruiting
Istituto Clinico Humanitas
Milan, 20089
- Recruiting
IRCCS Ospedale San Raffaele
Milan, IT 20132
- Recruiting
Istituto Europeo di Oncologia
Milan, IT 20141
- Recruiting
Sacro Cuore Hospital
Negrar, 37024
- Recruiting
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, IT 37024
- Suspended
Istituti Clinici Scientifici Maugeri
Pavia, 27100
- Suspended
Centro Nazionale di Adroterapia Oncoloica par il trattamento dei tumori
Pavia, IT 27100
- Recruiting
San Maria della Misericordia Hospital
Perugia, 06129
- Recruiting
Policlinico Universitario Campus Bio-Medico- Oncology Center
Roma, IT 00128
- Recruiting
Fondazione Policlinico Universitario A. Gemelli - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, IT 00168
- Recruiting
Azienda Ospedaliera Santa Maria di Terni
Terni, IT 05100
- Recruiting
Azienda Ospedaliera Citta della Salute e della Scienza di Torino - Universita Di Torino - San Giovanni Battista
Torino, 10126
Spain15 sites, 13 recruiting
- Recruiting
ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
Badalona, ES 08916
- Recruiting
Hospital Universitari Vall d'Hebron -Vall d'Hebron Institut Oncologia
Barcelona, ES 08035
- Recruiting
Hospital De La Santa Creu I Sant Pau
Barcelona, ES 08041
- Recruiting
Hospital General Universitario Santa Lucia
Cartagena, ES 30202
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, ES 14004
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
- Recruiting
Hospitales HM Sanchinarro-CIOCC
Madrid, 28050
- Recruiting
Hospital Universitario de La Princesa
Madrid, ES 28006
- Suspended
Hospital Universitario San Carlos
Madrid, ES 28040
- Suspended
Hospital Universitario de Navarra
Pamplona, ES 31008
- Recruiting
Hospital Universitario de Salamanca (430)
Salamanca, ES 37007
- Recruiting
Hospital Consorci Sanitari De Terrassa
Terrassa, ES 08227
- Recruiting
Hospital Clinico Universitario De Valencia
Valencia, ES 46010
- Recruiting
Hospital Universitario La Fe
Valencia, ES 46026
Belgium11 sites, 7 recruiting
- Suspended
Onze Lieve Vrouw Ziekenhuis
Aalst, 9300
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
- Recruiting
Institut Jules Bordet
Brussels, BE 1070
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
- Recruiting
AZ Sint-Lucas & Volkskliniek
Ghent, BE 9000
- Recruiting
AZ Groeninge Kortrijk - Campus Kennedylaan
Kortrijk, 8500
- Suspended
U.Z. Leuven - Campus Gasthuisberg
Leuven, BE 3000
- Suspended
C.H.U. Sart-Tilman
Liège, 4000
- Suspended
CHU Site Sainte-Elisabeth-UCL Namur
Namur, 5000
- Recruiting
AZ Turnhout - Campus Sint Elisabeth
Turnhout, BE 2300
- Recruiting
GasthuisZusters Antwerpen - Sint-Augustinus
Wilrijk, BE 2610
United Kingdom7 sites, 7 recruiting
- Recruiting
NHS Grampian - Aberdeen Royal Infirmary
Aberdeen, AB25 2ZD
- Recruiting
Velindre NHS Trust - Velindre Cancer Centre
Cardiff, CF14 2TL
- Recruiting
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital
Glasgow, GB G12 0YN
- Recruiting
The Christie NHS Foundation trust - The Christie NHS Foundation Trust
Manchester, M20 4BX
- Recruiting
The Clatterbridge cancer Center NHS foundation Trust - Clatterbridge Cancer Center - Wirral
Metropolitan Borough of Wirral, GB CH63 4JY
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital
Sheffield, S10 2SJ
- Recruiting
Somerset NHS Foundation Trust-Musgrove Park Hospital
Taunton, TA1 5DA
Switzerland6 sites, 5 recruiting
- Recruiting
Inselspital
Bern, 3010
- Recruiting
Kantonsspital Graubuenden
Chur, CH 7000
- Recruiting
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie
Geneva, 1211
- Suspended
Reseau Hospitalier Neuchatelois - RHNe - La Chaux de Fonds
La Chaux-de-Fonds, CH 2303
- Recruiting
Hopital du Valais - Hopital de Sion
Sion, 1951
- Recruiting
UniversitaetsSpital Zurich
Zurich, 8091
Germany5 sites, 3 recruiting
- Suspended
Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH
Aachen, DE 52074
- Suspended
Klinikum Bayreuth Gmbh
Bayreuth, DE 95448
- Recruiting
Universitaetsklinikum Carl Gustav Carus
Dresden, DE 01307
- Recruiting
Kliniken Maria Hilf GmbH
Mönchengladbach, DE 41063
- Recruiting
Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern
München, DE 81377
Netherlands4 sites, 4 recruiting
- Recruiting
Stichting Catharina Ziekenhuis
Eindhoven, NL 5623
- Recruiting
University Medical Center Groningen
Groningen, NL 9713 GZ
- Recruiting
Radboudumc - Radboud University Medical Center Nijmegen
Nijmegen, 6525
- Recruiting
Radiotherapiegroep Arnhem
Nijmegen, NL 6525 GA
Austria3 sites, 3 recruiting
- Recruiting
Medical University of Graz - Radio-oncology
Graz, AT 8036
- Recruiting
Ordensklinikum Linz-Barmherzige Schwestern
Linz, AT 4010
- Recruiting
Universitaetskliniken der Uni Wien - Universitaetsklinikum Wien - AKH unikliniken
Vienna, AT 1090
Ireland3 sites, 3 recruiting
- Recruiting
St Luke Hospital & SLRON - SLRON - St. Luke'S Hospital Rathgar
Dublin, IE 06
- Recruiting
Beacon Hospital
Dublin, IE D18 AK68
- Recruiting
University Hospital Galway
Galway, IE H91 YR71
Poland3 sites, 2 recruiting
- Recruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, PL 93-513
- Recruiting
Kliniki Neuroradiochirurgii Sp. z o.o.-Radomskie Centrum Onkologii
Radom, PL 26-600
- Suspended
Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, 02781
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Hradec Kralove
Hradec Králové, CZ 500 05
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center Tel Hashomer
Ramat Gan, IL 52621 60
Slovenia1 site, 1 recruiting
- Recruiting
The Institute Of Oncology
Ljubljana, SI 1000
About this study
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.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OligoCare | Patients with oligometastatic disease treated with radical radiotherapy | |
| ReCare | Patients treated with high-dose Re-irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients treated with radiotherapy enrolled in the program
Measured: 5 years
Secondary outcomes (5)
Disease free survival
Measured: 5 years
Loco-regional control
Measured: 5 years
Distant metastasis free survival
Measured: 5 years
Overall survival
Measured: 5 years
Incidence of adverse events related to radiotherapy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start24 Jun 2019
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818503
- Sponsor's protocol ID
- EORTC-1811
- Acronym
- E²-RADIatE
- Status last verified
- Mar 2025
- First submitted
- 17 Jan 2019
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Christ SM, Alongi F, Ricardi U, Scorsetti M, Livi L, Balermpas P, Lievens Y, Braam P, Jereczek-Fossa BA, Stellamans K, Ratosa I, Widder J, Peulen H, Dirix P, Bral S, Ramella S, Hemmatazad H, Khanfir K, Geets X, Jeene P, Zilli T, Fournier B, Ivaldi GB, Clementel E, Fortpied C, Oppong FB, Ost P, Guckenberger M. Cancer-specific dose and fractionation schedules in stereotactic body radiotherapy for oligometastatic disease: An interim analysis of the EORTC-ESTRO E2-RADIatE OligoCare study. Radiother Oncol. 2024 Jun;195:110235. doi: 10.1016/j.radonc.2024.110235. Epub 2024 Mar 19.
PubMed 38508239Nieder C, Willmann J, Andratschke NH. Prospective randomized clinical studies involving reirradiation: update of a systematic review. Strahlenther Onkol. 2023 Sep;199(9):787-797. doi: 10.1007/s00066-023-02118-1. Epub 2023 Jul 27.
PubMed 37500926
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E²-RADIatE: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe
- ClinicalTrials.gov ID
- NCT03818503
- Acronym / sponsor ID
- E²-RADIatE / EORTC-1811
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OligoCare | – | –Patients with oligometastatic disease treated with radical radiotherapy |
| ReCare | – | –Patients treated with high-dose Re-irradiation |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with various tumor types planned to be treated with radiation therapy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients treated with radiotherapy enrolled in the program
Time frame: 5 years
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Derived from this study: PubMed 38508239Christ SM, Alongi F, Ricardi U, Scorsetti M, Livi L, Balermpas P, Lievens Y, Braam P, Jereczek-Fossa BA, Stellamans K, Ratosa I, Widder J, Peulen H, Dirix P, Bral S, Ramella S, Hemmatazad H, Khanfir K, Geets X, Jeene P, Zilli T, Fournier B, Ivaldi GB, Clementel E, Fortpied C, Oppong FB, Ost P, Guckenberger M. Cancer-specific dose and fractionation schedules in stereotactic body radiotherapy for oligometastatic disease: An interim analysis of the EORTC-ESTRO E2-RADIatE OligoCare study. Radiother Oncol. 2024 Jun;195:110235. doi: 10.1016/j.radonc.2024.110235. Epub 2024 Mar 19.
- Derived from this study: PubMed 37500926Nieder C, Willmann J, Andratschke NH. Prospective randomized clinical studies involving reirradiation: update of a systematic review. Strahlenther Onkol. 2023 Sep;199(9):787-797. doi: 10.1007/s00066-023-02118-1. Epub 2023 Jul 27.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
77 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 77 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in Italy, Spain, Belgium, United Kingdom, Switzerland and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EORTC HQ (+32 2 774 1611, 1811@eortc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients treated with radiotherapy enrolled in the program (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03818503, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.