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

Sponsor
Instituto de Investigación Sanitaria Aragón
Study ID
NCT07779109
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 110 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Aug 21, 2026
Start date
Mar 30, 2026
Status verified
Aug 2026
Primary completion
Mar 30, 2030
Completion
Mar 30, 2035

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PURE cohort
    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).

Primary Outcome Measure

Acute GI and GU toxicity [ Time Frame: From enrollment to the end of treatment at 3 months ]

Central Contacts

  • Marta Gimeno Morales, MD, PhD
    +34 976 76 55 00
    [email protected]
  • Reyes Ibañez Carreras, PhD
    +34 976 76 55 00

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