Single-center post-operative stereotactic radiotherapy for endometrial cancer
Official title: a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer (SISTER-RAY)
Run by ARNAS Civico Di Cristina Benfratelli Hospital · NCT06360653 · Data updated 2026-11-12
This study will test whether a shorter, five‑fraction stereotactic radiotherapy course after surgery is safe and tolerable for adults with stage IB–IIIC1 endometrial cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | ARNAS Civico Di Cristina Benfratelli Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Palermo and 1 other locations) |
| Status | Recruiting |
| Started | May 2, 2025 |
| Main results expected | May 2026 |
| Study ends | May 2027 |
| Registry record updated | June 25, 2025 |
| Trial ID | NCT06360653 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 with surgically treated endometrial cancer (FIGO IB–IIIC1 of relevant histologies), ECOG ≤2 (or KPS ≥70), who are candidates for post-operative external beam radiotherapy and can consent are ideal candidates.
✕Probably not a fit
Patients with para‑aortic lymph node involvement, prior pelvic radiotherapy, active or past inflammatory bowel disease, or poor performance status (ECOG ≥3) are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center prospective study delivers stereotactic post-operative external beam radiotherapy in a shortened fractionation schedule to patients who have undergone surgery for endometrial cancer. The protocol focuses on a five‑fraction regimen intended to cover the surgical bed, upper vagina, and relevant pelvic nodal regions using modern IMRT/IGRT techniques. Primary and secondary outcomes include acute and late toxicity, quality of life measures, and clinical outcomes such as local control and recurrence. Chemotherapy and/or vaginal brachytherapy are permitted per clinical indication, while patients with prior pelvic radiotherapy, para‑aortic nodal involvement, or inflammatory bowel disease are excluded.
Why it matters
Potential benefit: If successful, this approach could shorten the post-operative radiation course, reducing time, travel, and treatment burden while maintaining safety and cancer control.
How similar studies have gone: Shorter, hypofractionated regimens have shown promise in other cancers such as prostate and breast, but post‑operative stereotactic pelvic radiotherapy for endometrial cancer remains relatively novel with limited published data.
Who can join: the full rules
Show full inclusion / exclusion criteria
* Age 18-80 years * ECOG PS ≤ 2 or KPS ≥ 70% * Patients diagnosed with endometrial cancer (endometrioid, serous cell, clear cell, carcinosarcoma) FIGO stage IB-IIIC1 candidate to post-operative external beam radiotherapy, based on molecular and histological findings * Indications for chemotherapy and/or brachytherapy are not exclusion criteria for the purpose of the study * Written Informed Consent Exclusion Criteria: * Prior pelvic radiotherapy * Para-aortic lymph nodes involvement * ECOG PS ≥ 3 * Any diagnosis of inflammatory bowel disease (both active or quiescent)
Where it's running
-
ARNAS Civico Hospital
Palermo, Italy Recruiting -
ARNAS Civico Hospital
Palermo, Italy Not yet recruiting
Study contacts
- Study coordinator: Francesco Cuccia, Md
- Email: francesco.cuccia@arnascivico.it
- Phone: +393334393336
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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.