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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-06-30 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07116213 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07116213 currently recruiting?
Yes, NCT07116213 is actively recruiting participants. Contact the research team at houxr@pumch.cn for enrollment information.
Where is the NCT07116213 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07116213 clinical trial?
NCT07116213 is sponsored by Xiaorong Hou. The trial plans to enroll 20 participants.
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