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NCT Number: NCT07779109

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

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.

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Key information

Conditions

SBRT Endometrial Cancer Endometrial Cancer Stage III Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female High-risk Endometrial Cancer Neoplasms Neoplasms by Site Radiation Therapy Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–110 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Unidad Clínica Multihospitalaria de Oncología Radioterápica de Aragón (UCMORA)

Zaragoza, 50009, Spain

Location status: Recruiting

Location contact

Marta Gimeno Morales, MD, PhD

CONTACT

[email protected]

+34 976 765500 ext. 142550

About this study

PURE is a prospective multicenter phase II safety study designed to evaluate ultra-hypofractionated adjuvant pelvic radiotherapy in patients with high-intermediate-risk and high-risk endometrial cancer. Eligible patients will receive 27.5 Gy in five fractions delivered over approximately two weeks using image-guided IMRT/VMAT. The study aims to determine whether this regimen achieves acceptable toxicity while preserving treatment efficacy and quality of life. Secondary endpoints include late toxicity, treatment compliance, patient-reported outcomes, locoregional control, disease-free survival, and overall survival. The study employs a Simon optimal two-stage design and plans to enroll 46 evaluable patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Acute GI and GU toxicity

    Time frame: From enrollment to the end of treatment at 3 months

    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.

Secondary outcomes

  1. Late GI and GU toxicity

    Time frame: From enrollment to the end of treatment at 12 months

    The proportion of participants experiencing late GI and GU toxicity will be reported, grade by CTCAE (G0-G5). Late toxicity will be defined at 6 and 12 months after the end of treatment.

  2. Evaluate patient-reported quality-of-life EORTC QLQ-C30

    Time frame: From enrollment to the end of treatment at 12 months

    Patient reported quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires (QLQ) C30 (EORTC QLQ-C30) for both the acute and late phases, during treatment, at 1, 3, 6 and 12 months after treatment.

    The EORTC QLQ-C30 uses a 4-point response scale for most items: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much.

    A higher score indicates worse quality of life.

  3. Evaluate patient-reported quality-of-life EORTC QLQ-EN24

    Time frame: From enrollment to the end of treatment at 12 months

    Patient reported quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Endometrial Cancer Module (EORTC QLQ-EN24) for both the acute and late phases, during treatment, at 1, 3, 6 and 12 months after treatment. The EORTC QLQ-EN24 uses a 4-point response scale for most items: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. A higher score indicates worse quality of life.

  4. Local control

    Time frame: From enrollment to the end of treatment at 5 years

    Evaluating absence of vaginal cuff recurrence during follows-up. Local control will be estimated using Kaplan-Meier analysis at 5 years.

  5. Regional control

    Time frame: From enrollment to the end of treatment at 5 years

    Evaluating absence of pelvic recurrence during follows-up. Local control will be estimated using Kaplan-Meier analysis at 5 years.

  6. Distant control

    Time frame: From enrollment to the end of treatment at 5 years

    Evaluating absence of distant recurrence during follows-up. Local control will be estimated using Kaplan-Meier analysis at 5 years.

  7. Disease free survival

    Time frame: From enrollment to the end of treatment at 5 years

    Evaluating patient survival free from any disease progression (local, regional, or distant) or death from any cause. Progression-free survival will be estimated using Kaplan-Meier analysis at 5 years.

Other outcomes

  1. Dosimetry caractheristics report

    Time frame: From enrollment to the end of treatment at 1 month

    Dosimetry descriptive report on target coverage and OAR constrains

Study contacts

Contact information is provided by the study sponsor or research team.

Marta Gimeno Morales, MD, PhD

CONTACT

[email protected]

+34 976 76 55 00

Reyes Ibañez Carreras, PhD

CONTACT

+34 976 76 55 00

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria Aragón

Other

Registry information

Official study title

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

Acronym: PURE-cohort

Important dates

Study start
2026
Primary completion
2030
Study completion
2035
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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