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Sponsor: Instituto de Investigación Sanitaria Aragón
Conditions: SBRT, Radiation Therapy, Endometrial Cancer, Endometrial Cancer Stage III, High-risk Endometrial Cancer
Interventions: Ultra-hypofractionation schedule of 27.5Gy in 5 fractions on image-guided adjuvant pelvic IMRT/VMAT radiotherapy
Countries: Spain
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.
Sex: FEMALE
Age: 18 Years to 110 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: 1. Aged \> 18 years. 2. Histologically confirmed diagnosis of endometrial cancer post hysterectomy: endometrial adenocarcinoma, serous or clear cell carcinoma, or carcinosarcoma or dedifferentiated carcinoma. 3. 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). 4. Patient is willing and able to give informed consent to participate in this clinical trial. 5. Patient must be willing and able to complete the QLQ-C30 questionnaire with EN-24 companion as described in the study protocol 6. Possibility of fiducial marker placement on vaginal vault. 7. Dosimetric feasibility based on OAR constraint and targets objective Exclusion Criteria: 1. Prior pelvic or abdominal radiation therapy delivered. 2. Inflamatory bowel disease of other contraindication to pelvic radiotherapy. 3. Previous abdominal or pelvic complicated surgery.
- Zaragoza, Zaragoza, Spain