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

NCT07779109 | Recruiting

• 1 other identifier: PI26/093
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SBRT; Radiation Therapy; Endometrial Cancer; Endometrial Cancer Stage III; High-risk Endometrial Cancer

Keywords

Endometrial cancer; Ultrahypofractionated Radiation Therapy; Postoperative pelvic radiation therapy; Postoperative pelvic sbrt; high-risk endometrial cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (7)

• Late GI and GU toxicity

  From enrollment to the end of treatment at 12 months

• Evaluate patient-reported quality-of-life EORTC QLQ-C30

  From enrollment to the end of treatment at 12 months

• Evaluate patient-reported quality-of-life EORTC QLQ-EN24

  From enrollment to the end of treatment at 12 months

• Local control

  From enrollment to the end of treatment at 5 years

• Regional control

  From enrollment to the end of treatment at 5 years

Other Outcomes (1)

• Dosimetry caractheristics report

  From enrollment to the end of treatment at 1 month

Study Arms (1)

PURE cohort

EXPERIMENTAL

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).

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

Interventions

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

Classically, 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.

PURE cohort

Eligibility Criteria

• Age: 18 Years - 110 Years
• Gender Eligibility Details: Endometrial cancer are exclusive female cancer type.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior pelvic or abdominal radiation therapy delivered.
• Inflamatory bowel disease of other contraindication to pelvic radiotherapy.
• Previous abdominal or pelvic complicated surgery.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead

Study Sites (1)

Unidad Clínica Multihospitalaria de Oncología Radioterápica de Aragón (UCMORA)

Zaragoza, Zaragoza, 50009, Spain

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Marta Gimeno Morales, MD, PhD

CONTACT

+34 976 76 55 00; ucmorapure@gmail.com

Reyes Ibañez Carreras, PhD

CONTACT

+34 976 76 55 00

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD. Radiation Oncology Staff from UCMORA. Clinical Professor.

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 21, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): March 30, 2030
• Study Completion (Estimated): March 30, 2035
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)