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NCT07779109Recruiting

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

Pelvic Ultra-Hypofractionated Adjuvant Radiotherapy for High-Intermediate and High-Risk Endometrial Cancer: A Prospective Multicenter Phase II Safety Cohort Study

Source: ClinicalTrials.gov · Last updated 25 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
29 Jul 2026
Start date
30 Mar 2026
Primary completion date
30 Mar 2030
Lead sponsor
Instituto de Investigación Sanitaria Aragón
NCT number
NCT07779109

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From 30 Mar 2026 to the primary completion date, 30 Mar 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior pelvic or abdominal radiation therapy delivered.
  • Previous abdominal or pelvic complicated surgery.

Other illness

  • Inflamatory bowel disease of other contraindication to pelvic radiotherapy.

Who the study is looking for

  • 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

Age in the registry: 18 years to 110 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Unidad Clínica Multihospitalaria de Oncología Radioterápica de Aragón (UCMORA)
Coordinator of this site? Confirm its status
ZaragozaSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.