Single-center post-operative stereotactic radiotherapy for endometrial cancer
a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer (SISTER-RAY)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | ARNAS Civico Di Cristina Benfratelli Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Palermo and 1 other locations) |
| Trial ID | NCT06360653 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Palermo and 1 other locations
- ARNAS Civico Hospital — Palermo, Italy (Not_yet_recruiting)
- ARNAS Civico Hospital — Palermo, Italy (Recruiting)
Study contacts
- Study coordinator: Francesco Cuccia, Md
- Email: francesco.cuccia@arnascivico.it
- Phone: +393334393336
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.