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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Xiaorong Hou, Professor
houxr@pumch.cn
+86 18612672203
Backup
Zihan Yan
yanzihan_zora@163.com
+8617860628938
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2030-12-30
Participants
Target number of participants: 20
Treatments
Experimental: Moderately Hypofractionated Adaptive Radiotherapy
Related Therapeutic Areas
Sponsors
Leads: Xiaorong Hou

This content was sourced from clinicaltrials.gov