Pelvic Ultra-Hypofractionated Adjuvant Radiotherapy for Endometrial Cancer (PURE-cohort)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-110
SponsorInstituto de Investigación Sanitaria Aragón

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Prior pelvic or abdominal radiation therapy delivered.

Inflamatory bowel disease of other contraindication to pelvic radiotherapy.

Previous abdominal or pelvic complicated surgery.

Trial design

Treatments tested in this trial

  • Ultra-hypofractionation schedule of 27.5Gy in 5 fractions on image-guided adjuvant pelvic IMRT/VMAT radiotherapy

Treatment groups

50 Participants
are divided into 1 treatment group