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
- Diseases
- Endometrial cancer
- 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
Sites (31)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| University Hospital Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Kantonsspital Frauenklinik Lucerne Coordinator of this site? Confirm its status | Lucerne | Switzerland | Unknown status |
| CEEGOG, General Faculty Hospital and First Faculty of Medicine, Charles University, Prague Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Sankt Gertrauden Krankenhaus Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Kaiserswerther Diakonie Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| Evang. Kliniken Essen-Mitte Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Universitätsklinikum Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Universitatsklinikum Schleswig-Holstein - Campus Lubeck Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| Rotkreuzklinikum München Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| University Hospital Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Hôpital Tenon Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| GINECO group - Institut Goustave Roussy Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CancerTrials Ireland - St James Hospital (SLRON SJH) Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| CancerTrials Ireland - St Luke's Hospital (SLRON SLH) Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| NKI / Antoni van Leeuwenhoekhuis Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Academic Medical Center Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Radiation Therapy Group Coordinator of this site? Confirm its status | Arnhem | Netherlands | Unknown status |
| Catharina hospital Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Unknown status |
| Zuidwest Radiotherapy Institute Coordinator of this site? Confirm its status | Flushing | Netherlands | Unknown status |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Radiotherapy Institute Friesland Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Unknown status |
| Leiden University Medical Center Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
| MAASTRO radiation oncology clinic Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| ErasmusMC Cancer Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Haaglanden Medical Center Coordinator of this site? Confirm its status | The Hague | Netherlands | Unknown status |
| Verbeeten Institute Coordinator of this site? Confirm its status | Tilburg | Netherlands | Unknown status |
| University Medical Center Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
| Isala Clinics Coordinator of this site? Confirm its status | Zwolle | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.