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 
2.4, 12 June 2018
Short Title
Portec 4a
Study site
Principle Investigator
C.L. Creutzberg
Investigator Maastro
L. Lutgens
Sponsor
Leiden University Medical Center (LUMC)
WHO Trial Registry
DUCG
ClinicalTrials.gov
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