Status:
ACTIVE_NOT_RECRUITING
PORTEC-4a: Molecular Profile-based Versus Standard Adjuvant Radiotherapy in Endometrial Cancer
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Dutch Cancer Society
Comprehensive Cancer Centre The Netherlands
Conditions:
Endometrial Cancer Stage I
Endometrial Cancer Stage II
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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 m...
Detailed Description
Adjuvant therapy for women with endometrial cancer has increasingly been tailored to prognostic factors to prevent overtreatment and select those women for adjuvant treatment who will have a clinicall...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
June 10 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT03469674
Start Date
June 10 2016
End Date
December 31 2028
Last Update
October 11 2023
Active Locations (31)
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1
Medical University, Vienna
Vienna, Austria
2
University Hospital Gent
Ghent, Belgium
3
CEEGOG, General Faculty Hospital and First Faculty of Medicine, Charles University, Prague
Prague, Czechia
4
GINECO group - Institut Goustave Roussy
Paris, France