PORTEC-4a: Molecular Profile-based Versus Standard Adjuvant Radiotherapy in Endometrial Cancer
NCT ID: NCT03469674
Last Updated: 2023-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
550 participants
INTERVENTIONAL
2016-06-10
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Randomized Trial of Radiation Therapy With or Without Chemotherapy for Endometrial Cancer
NCT00411138
Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Endometrial Cancer
NCT01041027
PROfiling Based Endometrial Cancer Adjuvant Therapy
NCT05179447
Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer
NCT00005583
Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Advanced Endometrial Cancer
NCT00002493
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Molecular profile based treatment
Determination of the integrated clinicopathological and molecular profile to determine adjuvant treatment: observation for favourable profile; vaginal brachytherapy for intermediate profile; external beam radiotherapy for unfavourable profile
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
Vaginal brachytherapy
Adjuvant vaginal brachytherapy (standard treatment)
Vaginal brachytherapy
Internal radiation of the vaginal vault using a vaginal cylinder, 21 Gy in 3 out-patient sessions over 2 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Stage IA, grade 3 (any age, with or without LVSI)
2. Stage IB, grade 1 or 2 and age \>60 years
3. Stage IB, grade 1-2 with documented LVSI
4. Stage IB, grade 3 without LVSI
5. Stage II (microscopic), grade 1
* World Health Organization (WHO)-performance status 0-2
* Written informed consent
Exclusion Criteria
* Histological types serous carcinoma or clear cell carcinoma (at least 10% if mixed type), or undifferentiated or neuroendocrine carcinoma
* Uterine sarcoma (including carcinosarcoma)
* Previous malignancy (except for non-melanomatous skin cancer) \< 5 yrs
* Previous pelvic radiotherapy
* Expected interval between the operation and start of radiotherapy exceeding 8 weeks
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dutch Cancer Society
OTHER
Comprehensive Cancer Centre The Netherlands
OTHER
Leiden University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Carien Creutzberg
Chief Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carien L. Creutzberg, MD, PhD
Role: STUDY_CHAIR
Leiden University Medical Center, Dept of Radiation Oncology
Remi A. Nout, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
ErasmusMC Dept of Radiation Oncology
Anne-Sophie van den Heerik, MD
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center, Dept of Radiation Oncology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Nero C, Ciccarone F, Pietragalla A, Duranti S, Daniele G, Scambia G, Lorusso D. Adjuvant Treatment Recommendations in Early-Stage Endometrial Cancer: What Changes With the Introduction of The Integrated Molecular-Based Risk Assessment. Front Oncol. 2021 Sep 1;11:612450. doi: 10.3389/fonc.2021.612450. eCollection 2021.
van den Heerik ASVM, Horeweg N, Nout RA, Lutgens LCHW, van der Steen-Banasik EM, Westerveld GH, van den Berg HA, Slot A, Koppe FLA, Kommoss S, Mens JWM, Nowee ME, Bijmolt S, Cibula D, Stam TC, Jurgenliemk-Schulz IM, Snyers A, Hamann M, Zwanenburg AG, Coen VLMA, Vandecasteele K, Gillham C, Chargari C, Verhoeven-Adema KW, Putter H, van den Hout WB, Wortman BG, Nijman HW, Bosse T, Creutzberg CL. PORTEC-4a: international randomized trial of molecular profile-based adjuvant treatment for women with high-intermediate risk endometrial cancer. Int J Gynecol Cancer. 2020 Dec;30(12):2002-2007. doi: 10.1136/ijgc-2020-001929. Epub 2020 Oct 12.
Wortman BG, Bosse T, Nout RA, Lutgens LCHW, van der Steen-Banasik EM, Westerveld H, van den Berg H, Slot A, De Winter KAJ, Verhoeven-Adema KW, Smit VTHBM, Creutzberg CL; PORTEC Study Group. Molecular-integrated risk profile to determine adjuvant radiotherapy in endometrial cancer: Evaluation of the pilot phase of the PORTEC-4a trial. Gynecol Oncol. 2018 Oct;151(1):69-75. doi: 10.1016/j.ygyno.2018.07.020. Epub 2018 Aug 3.
Related Links
Access external resources that provide additional context or updates about the study.
Study website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UL2011-5336
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ISRCTN11659025
Identifier Type: REGISTRY
Identifier Source: secondary_id
NTR5841
Identifier Type: REGISTRY
Identifier Source: secondary_id
P16.054
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.