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NCT03469674Active, not recruitingPhase 3

PORTEC-4a: Molecular Profile-based Versus Standard Adjuvant Radiotherapy in Endometrial Cancer

Randomised Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Radiotherapy for Women With Early Stage Endometrial Cancer: PORTEC-4a Trial

Source: ClinicalTrials.gov · Last updated 11 Oct 2023

Brief summary (registry, in English)

This is prospective, multicenter, randomised phase III trial among women with endometrial cancer with high-intermediate risk features to investigate the role of an integrated clinicopathological and molecular risk profile to determine if participants should receive no adjuvant therapy, vaginal brachytherapy or external beam radiotherapy based on a favourable, intermediate or unfavourable profile as compared to standard adjuvant vaginal brachytherapy.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
550 (estimated)
First submitted
8 Mar 2018
Start date
10 Jun 2016
Primary completion date
31 Dec 2024
Lead sponsor
Leiden University Medical Center
NCT number
NCT03469674

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 550
  • From 10 Jun 2016 to the primary completion date, 31 Dec 2024
  • 31 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous pelvic radiotherapy
  • Expected interval between the operation and start of radiotherapy exceeding 8 weeks

Age

  • Previous malignancy (except for non-melanomatous skin cancer) \< 5 yrs

Other

  • Any other stage and type of endometrial carcinoma
  • Histological types serous carcinoma or clear cell carcinoma (at least 10% if mixed type), or undifferentiated or neuroendocrine carcinoma
  • Uterine sarcoma (including carcinosarcoma)

Who the study is looking for

  • Histologically confirmed endometrioid type endometrial carcinoma, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage I, with one of the following combinations of stage, grade, age, and lymph-vascular space invasion (LVSI):
    • Stage IA, grade 3 (any age, with or without LVSI)
    • Stage IB, grade 1 or 2 and age \>60 years
    • Stage IB, grade 1-2 with documented LVSI
    • Stage IB, grade 3 without LVSI
    • Stage II (microscopic), grade 1
  • World Health Organization (WHO)-performance status 0-2
  • Written informed consent

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (31)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University Vienna
Coordinator of this site? Confirm its status
ViennaAustriaUnknown status
University Hospital Gent
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GhentBelgiumUnknown status
Kantonsspital Frauenklinik Lucerne
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LucerneSwitzerlandUnknown status
CEEGOG, General Faculty Hospital and First Faculty of Medicine, Charles University, Prague
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PragueCzechiaUnknown status
Sankt Gertrauden Krankenhaus
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BerlinGermanyUnknown status
Kaiserswerther Diakonie
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DüsseldorfGermanyUnknown status
Evang. Kliniken Essen-Mitte
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EssenGermanyUnknown status
Universitätsklinikum Heidelberg
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HeidelbergGermanyUnknown status
Universitatsklinikum Schleswig-Holstein - Campus Lubeck
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LübeckGermanyUnknown status
Rotkreuzklinikum München
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MunichGermanyUnknown status
University Hospital
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TübingenGermanyUnknown status
Hôpital Tenon
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ParisFranceUnknown status
Hôpital Européen Georges Pompidou
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ParisFranceUnknown status
GINECO group - Institut Goustave Roussy
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ParisFranceUnknown status
CancerTrials Ireland - St James Hospital (SLRON SJH)
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DublinIrelandUnknown status
CancerTrials Ireland - St Luke's Hospital (SLRON SLH)
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DublinIrelandUnknown status
NKI / Antoni van Leeuwenhoekhuis
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AmsterdamNetherlandsUnknown status
Academic Medical Center
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AmsterdamNetherlandsUnknown status
Radiation Therapy Group
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ArnhemNetherlandsUnknown status
Catharina hospital
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EindhovenNetherlandsUnknown status
Zuidwest Radiotherapy Institute
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FlushingNetherlandsUnknown status
University Medical Center Groningen
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GroningenNetherlandsUnknown status
Radiotherapy Institute Friesland
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LeeuwardenNetherlandsUnknown status
Leiden University Medical Center
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LeidenNetherlandsUnknown status
MAASTRO radiation oncology clinic
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MaastrichtNetherlandsUnknown status
Radboud University Medical Center
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NijmegenNetherlandsUnknown status
ErasmusMC Cancer Center
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RotterdamNetherlandsUnknown status
Haaglanden Medical Center
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The HagueNetherlandsUnknown status
Verbeeten Institute
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TilburgNetherlandsUnknown status
University Medical Center Utrecht
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UtrechtNetherlandsUnknown status
Isala Clinics
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ZwolleNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.