Endometrial cancer Uterine cancer Endometrial carcinoma Endometriumcarcinoom Baarmoederkanker
Conditions
Interventions
Arm 1 (standard): vaginal brachytherapy
Arm 2 (molecular profile based recommendations for adjuvant treatment): observation, vaginal brachytherapy or external beam radiotherapy
Sponsors
Leiden University Medical Center (LUMC)
Eligibility
Inclusion criteria
Inclusion criteria: 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 WHO-performance status 0-2 Written informed consent
Exclusion criteria
Exclusion criteria: Any other stage and type of endometrial carcinoma Histological types papillary 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 Interval between the operation and start of radiotherapy exceeding 8 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vaginal recurrence | — |
Secondary
| Measure | Time frame |
|---|---|
| recurrence-free survival pelvic and distant recurrence patient-reported quality of life adverse events health care costs | — |
Contacts
Public ContactKaren Verhoeven-Adema
IKNL
Outcome results
None listed