Moderately hypofractionated adaptive postoperative radiotherapy for high-risk endometrial cancer

Clinical Research on Moderately Hypofractionated Adaptive Postoperative Radiotherapy for High-Risk Endometrial Cancer

This study will test a shorter, adaptive postoperative radiation schedule for people with high-risk endometrial cancer to shorten treatment time while watching for side effects and cancer control.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Peking Union Medical College Hospital (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07116213 on ClinicalTrials.gov

What this trial studies

This single-center, single-arm prospective study enrolled 20 patients who received online adaptive external beam radiotherapy using a moderate hypofractionation schedule (40.05 Gy in 15 fractions) to the vagina and pelvic nodal regions, with optional 3D intracavitary brachytherapy after EBRT and chemotherapy sequencing as clinically indicated. The department's existing online adaptive radiotherapy (oART) workflow was used for simulation, planning, plan adaptation, and treatment delivery. Primary endpoint was incidence of acute toxicity, with secondary endpoints including 3-year failure-free survival, chronic toxicity, quality of life, and treatment costs. Patients were followed during treatment and then at the end of radiotherapy, 3 and 6 months post-treatment, and every 6 months up to 3 years.

Who should consider this trial

Good fit: Adults aged 18–70 with high-risk endometrial cancer after total hysterectomy and bilateral salpingo-oophorectomy (ECOG 0–2) meeting the specified FIGO-stage and histology criteria who can complete the oART workflow are ideal candidates.

Not a fit: Patients with prior abdominal or pelvic radiotherapy, poor performance status, disease outside the study's stage/histology criteria, or inability to attend the single Beijing center or comply with oART are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could allow effective postoperative radiation with fewer treatment sessions, reducing patient time and resource use while maintaining acceptable toxicity and cancer control.

How similar studies have performed: Moderately hypofractionated postoperative regimens and adaptive radiotherapy have shown promising toxicity and control in limited series, but this exact combination for high-risk endometrial cancer remains relatively novel and not yet widely validated.

Eligibility criteria

Inclusion Criteria:

* Age : 18-70 years old.
* Performance Status :

ECOG score 0-2.

* Expected to comply with oART (Online Adaptive Radiotherapy) workflow.
* Initial Surgical Treatment :

Total hysterectomy and bilateral salpingo-oophorectomy ± Pelvic and/or para-aortic lymph node dissection/sampling or sentinel lymph node biopsy.

* Pathological Staging \& Histology (per FIGO 2009):

Stage I :

Grade 3 endometrioid adenocarcinoma with superficial myometrial invasion and extensive LVSI (Lymphovascular Space Invasion).

Grade 2 endometrioid adenocarcinoma with deep myometrial invasion and extensive LVSI.

Grade 3 endometrioid adenocarcinoma with deep myometrial invasion. Stage II-IIIC1 : Endometrioid carcinoma. Stage I-IIIC1 : Serous carcinoma or clear cell carcinoma.

* Informed Consent :
* Patients and families fully understand the study protocol.
* Voluntarily participate and sign informed consent forms before enrollment

Exclusion Criteria:

* Prior Radiotherapy : History of abdominal or pelvic irradiation.
* Treatment Interval :

Without adjuvant chemotherapy: \>12 weeks between surgery and radiotherapy initiation.

With adjuvant chemotherapy: \>6 months between surgery and radiotherapy initiation.

* Malignancy History : Prior diagnosis of other malignancies.
* Pregnancy/Lactation : Pregnant or breastfeeding women.
* Active Infection : Fever or uncontrolled active infection.
* Inflammatory Bowel Disease (IBD) : History of IBD (regardless of activity status).
* Comorbidities : Severe conditions affecting trial compliance, including: Unstable cardiac disease requiring treatment, renal impairment, chronic hepatitis, poorly controlled diabetes, psychiatric disorders

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Xiaorong Hou, Professor

Conditions: Endometrial Cancer, Hypofractionated Dose, Radiotherapy, Adjuvant, Side Effects, Survival , Tumor, endometrial cancer, Hypofractionated dose, Radiotherapy