Randomised Phase Ill Trial of molecular profile-based versus standard recommendations for adjuvant radiotherapy for women with early stage endometrial cancer: PORTEC-4a

Randomised Phase Ill Trial of molecular profile-based versus standard recommendations for adjuvant radiotherapy for women with early stage endometrial cancer: PORTEC-4a - PORTEC-4a

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54837

Enrollment

438

Registered

2016-02-11

Start date

2016-06-10

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial cancer

Interventions

Patients in the standard arm will be treated with vaginal brachytherapy (21 Gy HDR in 3 fractions of 7 Gy each, specified at 5 mm from the applicator surface and top, within overall time of 2 weeks)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult patients with histologically confirmed endometrioid type endometrial carcinoma, FIGO 2009 stage I, with one of the following combinations of stage, grade, age, and LVSI: 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 Surgery consisted of Total Abdominal or Laparoscopic Hysterectomy and Bilateral Salpingo-Oophorectomy (TH-BSO) with or without pelvic lymphadenectomy, lymph node sampling or sentinel node procedure (not recommended, but permitted) WHO-performance status 0-2 Written informed consent

Exclusion criteria

Exclusion criteria: The following criteria exclude the patient from enrolment in this trial: 1. Any other stage and type of endometrial. carcinoma 2. Non-endometrioid endometrial carcinoma, such as serous or clear cell carcinoma (at least 10% in mixed types), or undifferentiated or neuroendocrine carcinoma 3. Uterine sarcoma (including carcinosarcoma) 4. Previous malignancy (except for non-melanomatous skin cancer)

Design outcomes

Primary

Measure	Time frame
Primary endpoint: vaginal recurrence	—

Secondary

Measure	Time frame
Secondary endpoints: Adverse events and patient-reported symptoms and health-related quality of life Recurrence-free and overall survival Pelvic and distant recurrence 5-year vaginal control (including treatment for relapse if applicable) Endometrial cancer - related healthcare costs	—

Countries

Austria, Belgium, France, Germany, Ireland, Netherlands, Switzerland

Contacts

Public ContactC.L. Creutzberg

Leids Universitair Medisch Centrum

c.l.creutzberg@lumc.nl0715265120

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 27, 2026