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.
Prior pelvic or abdominal radiation therapy delivered.
Inflamatory bowel disease of other contraindication to pelvic radiotherapy.
Previous abdominal or pelvic complicated surgery.
Single group
Ultra-hypofractionation schedule of 27.5Gy in 5 fractions on image-guided adjuvant pelvic IMRT/VMAT radiotherapy
RadiationClassically, the dose prescribed for adjuvant treatment of endometrial cancer were 45-50Gy in conventional fractionation 1.8Gy/fx, in a total 25-28fx. The shedule proposed on this prospective cohort of 27.5Gy in 5 fractions on image-guided adjuvant pelvic IMRT/VMAT radiotherapy.
Acute GI and GU toxicity
The proportion of participants experiencing acute GI and GU toxicity will be reported, grade by CTCAE (G0-G5). Acute toxicity will be defined during treatment, at 1 and 3 months after the end of treatment.
Late GI and GU toxicity
The proportion of participants experiencing late GI and GU toxicity will be reported, grade by CTCAE (G0-G5). Late toxicity will be defined at 6 and 12 months after the end of treatment.
Evaluate patient-reported quality-of-life EORTC QLQ-C30
Patient reported quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires (QLQ) C30 (EORTC QLQ-C30) for both the acute and late phases, during treatment, at 1, 3, 6 and 12 months after treatment. The EORTC QLQ-C30 uses a 4-point response scale for most items: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. A higher score indicates worse quality of life.
Evaluate patient-reported quality-of-life EORTC QLQ-EN24
Patient reported quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Endometrial Cancer Module (EORTC QLQ-EN24) for both the acute and late phases, during treatment, at 1, 3, 6 and 12 months after treatment. The EORTC QLQ-EN24 uses a 4-point response scale for most items: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. A higher score indicates worse quality of life.
Local control
Evaluating absence of vaginal cuff recurrence during follows-up. Local control will be estimated using Kaplan-Meier analysis at 5 years.
Dosimetry caractheristics report
Dosimetry descriptive report on target coverage and OAR constrains
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