Pelvic ultra-hypofractionated radiotherapy after surgery for high-risk endometrial cancer
Official title: Pelvic Ultra-Hypofractionated Adjuvant Radiotherapy for High-Intermediate and High-Risk Endometrial Cancer: A Prospective Multicenter Phase II Safety Cohort Study
Run by Instituto de Investigación Sanitaria Aragón · NCT07779109 · Data updated 2026-11-12
This trial tests whether giving 27.5 Gy in five sessions of pelvic radiotherapy after surgery is safe and feasible for high-risk endometrial cancer patients.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 110 Years |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | Instituto de Investigación Sanitaria Aragón Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Zaragoza, Zaragoza) |
| Status | Recruiting |
| Started | March 30, 2026 |
| Main results expected | March 30, 2030 |
| Study ends | March 30, 2035 |
| Registry record updated | August 25, 2026 |
| Trial ID | NCT07779109 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with histologically confirmed endometrial cancer post-hysterectomy at high-intermediate or high risk who are candidates for adjuvant pelvic radiotherapy.
✕Probably not a fit
Patients with prior pelvic radiation, inflammatory bowel disease, or other contraindications to pelvic radiotherapy may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, single-arm phase II study evaluating ultra-hypofractionated pelvic radiotherapy after surgery for high-intermediate- and high-risk endometrial cancer. Patients receive 27.5 Gy in five fractions with image-guided IMRT/VMAT, aiming to limit acute GI and GU toxicity while maintaining efficacy. Secondary outcomes include late toxicity, treatment adherence, patient-reported quality of life, locoregional control, disease-free survival, and overall survival, using a Simon two-stage design to enroll up to 46 evaluable patients. The trial will determine if this shorter, modern radiotherapy approach can be safely implemented in routine practice.
Why it matters
Potential benefit: If successful, patients may receive effective pelvic radiation with potentially shorter treatment time and acceptable toxicity.
How similar studies have gone: Similar ultra-hypofractionation approaches in other pelvic cancers have shown manageable toxicity in early studies, but this exact regimen in endometrial cancer is being evaluated.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Unidad Clínica Multihospitalaria de Oncología Radioterápica de Aragón (UCMORA)
Zaragoza, Zaragoza, Spain Recruiting
Study contacts
- Study coordinator: Marta Gimeno Morales, MD, PhD
- Email: ucmorapure@gmail.com
- Phone: +34 976 76 55 00
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.