Cancer types
  • Gynaecology
Title of study
Randomised Phase III Trial of molecular profile-based versus standard recommendations for adjuvant radiotherapy for women with early stage endometrial cancer
Version Number
Approval Date 
2.5.1, approval date 30-06-2020
Short Title
Portec 4a
Study site
Principle Investigator
C.L. Creutzberg
Investigator Maastro
L. Lutgens
Sponsor
Leiden University Medical Center (LUMC)
Trial registry
Objectives 

Establish vaginal recurrence and recurrence-free survival in patients with high-intermediate risk endometrial carcinoma, treated after surgery with standard vaginal brachytherapy (21 Gy in 3 fractions), in comparison with molecular risk profile based recommendations for no additional treatment (55%), vaginal brachytherapy (40%) or external beam radiotherapy (5%)

Primary Endpoint 

Vaginal recurrence, second primary endpoint is recurrence-free survival

Secondary Endpoints 

Secondary endpoints are adverse events, patient-reported symptoms and quality of life, pelvic and distant recurrence, 5-year vaginal control including treatment for relapse, overall survival, and EC-related healthcare costs