Moderately hypofractionated adaptive postoperative radiotherapy for high-risk endometrial cancer

Is this trial a fit for you?

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, 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.

Why it matters

Who can join: the full rules

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 it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaorong Hou, Professor
• Email: houxr@pumch.cn
• Phone: +86 18612672203

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.