RecruitingNot ApplicableNCT07116213

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

Sponsor

Xiaorong Hou

Enrollment

20 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

Endometrial Cancer Side Effects Radiotherapy, Adjuvant Hypofractionated Dose Survival , Tumor

Summary

1. Study Type: Single-center, single-arm, prospective study. 2. Sample Size: 20 patients with high-risk endometrial cancer were enrolled. 3. Treatment Procedure: The existing clinical oART (Online Adaptive Radiotherapy) workflow protocol for malignant tumors used in our department was applied. Procedures included simulation, target volume delineation, radiotherapy planning, and treatment delivery. External beam radiation therapy (EBRT) was delivered using moderate hypofractionation. If indicated, brachytherapy was performed after the completion of EBRT. When combined with chemotherapy, radiotherapy could be administered during chemotherapy intervals or after completion of chemotherapy. 4. Study Endpoints: Primary Endpoint: Incidence of acute toxicity. Secondary Endpoints: 3-year failure-free survival (FFS) rate, incidence of chronic toxicity, quality of life (QoL), treatment costs, etc.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria14

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 Criteria9

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