NCT07116213 Clinical Research on Moderately Hypofractionated Adaptive Postoperative Radiotherapy for High-Risk Endometrial Cancer
| NCT ID | NCT07116213 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xiaorong Hou |
| Condition | Endometrial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-06-30 |
| Primary Completion | 2029-06-30 |
Trial Parameters
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Brief 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 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 pel
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