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

Instituto de Investigación Sanitaria Aragón50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

SBRT Radiation Therapy

Interventions

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

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 110 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged \> 18 years. 2. Histologically confirmed diagnosis of endometrial cancer post hysterectomy: endometrial adenocarcinoma, serous or clear cell carcinoma, or carcinosarcoma or dedifferentiated carcinoma. 3. 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). 4. Patient is willing and able to give informed consent to participate in this clinical trial. 5. Patient must be willing and able to complete the QLQ-C30 questionnaire with EN-24 companion as described in the study protocol 6. Possibility of fiducial marker placement on vaginal vault. 7. Dosimetric feasibility based on OAR constraint and targets objective Exclusion Criteria: 1. Prior pelvic or abdominal radiation therapy delivered. 2. Inflamatory bowel disease of other contraindication to pelvic radiotherapy. 3. Previous abdominal or pelvic complicated surgery.

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Late GI and GU toxicity

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.

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

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

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.

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

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

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.

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

Local control

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

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

Regional control

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

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

Distant control

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

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

Disease free survival

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.

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts