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PORTEC-4a: Molecular Profile-based Versus Standard Adjuvant Radiotherapy in Endometrial Cancer
Sponsor: Leiden University Medical Center
Summary
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.
Official title: Randomised Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Radiotherapy for Women With Early Stage Endometrial Cancer: PORTEC-4a Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
550
Start Date
2016-06-10
Completion Date
2028-12-31
Last Updated
2023-10-11
Healthy Volunteers
No
Interventions
Vaginal brachytherapy
Internal radiation of the vaginal vault using a vaginal cylinder, 21 Gy in 3 out-patient sessions over 2 weeks
External beam radiotherapy
External beam pelvic radiotherapy on a linear accelerator, 48.6 Gy in 27 out-patients sessions over 5.5 weeks
Observation
No radiation therapy, but active follow-up and quality of life questionnaires as in the groups who have adjuvant treatment
Locations (31)
Medical University, Vienna
Vienna, Austria
University Hospital Gent
Ghent, Belgium
CEEGOG, General Faculty Hospital and First Faculty of Medicine, Charles University, Prague
Prague, Czechia
GINECO group - Institut Goustave Roussy
Paris, France
Hôpital Européen Georges-Pompidou
Paris, France
Hôpital Tenon
Paris, France
Sankt Gertrauden Krankenhaus
Berlin, Germany
Kaiserswerther Diakonie
Düsseldorf, Germany
Evang. Kliniken Essen-Mitte
Essen, Germany
Universitatsklinikum Heidelberg
Heidelberg, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, Germany
Rotkreuzklinikum München
Münich, Germany
University Hospital
Tübingen, Germany
CancerTrials Ireland - St James Hospital (SLRON SJH)
Dublin, Ireland
CancerTrials Ireland - St Luke's Hospital (SLRON SLH)
Dublin, Ireland
Academic Medical Center
Amsterdam, Netherlands
NKI / Antoni van Leeuwenhoekhuis
Amsterdam, Netherlands
Radiation Therapy Group
Arnhem, Netherlands
Catharina Hospital
Eindhoven, Netherlands
Zuidwest Radiotherapy Institute
Flushing, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Radiotherapy Institute Friesland
Leeuwarden, Netherlands
Leiden University Medical Center
Leiden, Netherlands
MAASTRO radiation oncology clinic
Maastricht, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
ErasmusMC Cancer Center
Rotterdam, Netherlands
Haaglanden Medical Center
The Hague, Netherlands
Verbeeten institute
Tilburg, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Isala Clinics
Zwolle, Netherlands
Kantonsspital Frauenklinik Lucerne
Lucerne, Switzerland