Endometrial cancer Cancer
Conditions
Interventions
Participants are randomly allocated to one of two arms:
1. Standard arm:
Vaginal brachytherapy (3 short outpatient internal radiation treatments over 2 weeks to the vaginal cuff), based on PORTEC-2
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
Female
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: 1. Any other stage and type of endometrial carcinoma 2, Histological types papillary serous carcinoma or clear cell carcinoma (at least 10% if mixed type) 3. Undifferentiated or neuroendocrine carcinoma 4. Uterine sarcoma (including carcinosarcoma) 5. Previous malignancy (except for non-melanomatous skin cancer) < 5 yrs 6. Previous pelvic radiotherapy 7. Interval between the operation and start of radiotherapy exceeding 8 weeks Updated 17/08/2021: 7. Expected interval between the operation and start of radiotherapy exceeding 8 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaginal recurrence, measured during each follow-up visit by vaginal inspection and pelvic examinations (3 monthly first 2 years, 6 monthly until 5th year) and confirmation by histology in case of suspected recurrence | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recurrence-free survival - regular follow-up visits (3 monthly first 2 years, 6 monthly until 5th year) with history focused on symptoms and side effects and pelvic examination; further evaluation in case of suspected recurrence locally or at distant sites by (PET)-CT and/or MRi scanning and histological confirmation. In case of death, information on date and cause of death are recorded 2. 5-year vaginal control - local recurrence free at 5 years either without any evidence of recurrence or after treatment for vaginal recurrence 3. Quality of life- Patients receive a QoL questionnaire consisting of EORTC QLQ-C30 and EN24 at baseline (after surgery, before study treatment or observation), at 6 weeks after randomisation, and at 6, 12, 18, 24, 36 and 60 months after randomisation 4. Side effects- Regular follow-up visits (3 monthly first 2 years, 6 monthly until 5th year) with history focused on symptoms and side effects – recording of adverse events according to CTCAEv 4.0 5. Health care costs - EC-related healthcare costs will include the costs of the randomised care and care associated with (serious) adverse events. Healthcare use over the follow-up period will be converted to costs using standard prices, discounted over time. Costs will be evaluated at each follow-up and at recurrence by recording hospital admissions, surgeries, etc over the past follow-up period | — |
Countries
Austria, Belgium, Czech Republic, France, Germany, Ireland, Netherlands, Switzerland
Outcome results
None listed