Pelvic Ultra-Hypofractionated Adjuvant Radiotherapy for High-Intermediate and High-Risk Endometrial Cancer: A Prospective Multicenter Phase II Safety Cohort Study
The PURE trial is a prospective multicenter phase II study evaluating the safety and feasibility of ultra-hypofractionated adjuvant pelvic radiotherapy in patients with high-intermediate-risk and high-risk endometrial cancer following surgery. The study investigates a treatment regimen consisting of 27.5 Gy delivered in five fractions using modern image-guided IMRT/VMAT techniques. The primary objective is to assess acute gastrointestinal and genitourinary toxicity according to CTCAE version 5.0.
• Aged \> 18 years.
• Histologically confirmed diagnosis of endometrial cancer post hysterectomy: endometrial adenocarcinoma, serous or clear cell carcinoma, or carcinosarcoma or dedifferentiated carcinoma.
• Patients candidates for adjuvant pelvic (Cht)EBRT treatment (+/- vaginal cuff brachytherapy), categorized by Intermediate-high risk and high risk primary endometrial cancer based on recent ESGO/ESTRO/ESMO Guidelines (2025).
• Patient is willing and able to give informed consent to participate in this clinical trial.
• Patient must be willing and able to complete the QLQ-C30 questionnaire with EN-24 companion as described in the study protocol
• Possibility of fiducial marker placement on vaginal vault.
• Dosimetric feasibility based on OAR constraint and targets objective