Endometrial Cancer, Endometrial Cancer Stage III, High-risk Endometrial Cancer, Radiation Therapy, SBRT
Conditions
Keywords
Endometrial cancer, Ultrahypofractionated Radiation Therapy, Postoperative pelvic radiation therapy, Postoperative pelvic sbrt, high-risk endometrial cancer
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.
Detailed description
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.
Interventions
RADIATIONUltra-hypofractionation schedule of 27.5Gy in 5 fractions on image-guided adjuvant pelvic IMRT/VMAT radiotherapy
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.
Sponsors
Instituto de Investigación Sanitaria Aragón
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 110 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute GI and GU toxicity | 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
| Measure | Time frame | Description |
|---|---|---|
| Late GI and GU toxicity | 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. |
| Evaluate patient-reported quality-of-life EORTC QLQ-C30 | 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. |
| Evaluate patient-reported quality-of-life EORTC QLQ-EN24 | 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. |
| Local control | 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. |
| Regional control | 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. |
| Distant control | 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. |
| Disease free survival | 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. |
Countries
Spain
Contacts
CONTACTMarta Gimeno Morales, MD, PhD
CONTACTReyes Ibañez Carreras, PhD
Outcome results
None listed