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.
Research Process 1. Baseline Assessment Includes medical history inquiry, physical examination, and relevant laboratory/imaging tests. Complete the pre-radiotherapy Quality of Life Scale. 2. Treatment Plan External Beam Radiotherapy (EBRT): Utilize online adaptive radiotherapy technology to irradiate the vagina and pelvic lymph node drainage areas. Employ moderate fractionation. Prescription Dose: 40.05 Gy / 15 fractions, administered once daily, five times per week. Brachytherapy: Commence after completion of EBRT. Utilize 3D intracavitary brachytherapy technology. Fraction Dose: 4-6 Gy, for a total of 2-3 fractions, administered with an interval of 1-2 days between fractions. 3\. Follow-up Visits 1. During Radiotherapy: Monitor CBC weekly and Biochemistry Panel every 2 weeks. Perform radiotherapy-related toxicity assessment. 2. Post-Radiotherapy: Timepoints: End of radiotherapy; 3 months post-radiotherapy; 6 months post-radiotherapy; then every 6 months thereafter, until 3 years post-radiotherapy. Follow-up Content: Includes medical history inquiry, physical examination, and Quality of Life assessment; Laboratory/Imaging Tests.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Moderately Hypofractionated Adaptive Postoperative Radiotherapy
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGAcute toxicity
Toxicities occurring \<90 days from radiotherapy initiation. Evaluated using CTCAE v5.0.
Time frame: <90 days after treatment initiation
3-year failure-free survival
The time from treatment initiation until the occurrence of any treatment failure events.
Time frame: From date of surgery to the 3 years after treatment initiation
Chronic Toxicity
Toxicities occurring ≥90 days from radiotherapy initiation. Evaluated using the RTOG Late Morbidity Scoring Schema.
Time frame: ≥90 days after treatment initiation
Quality of Life (EORTC QLQ-C30/EORTC QLQ-EN24)
EORTC QLQ-C30: This is a core quality of life questionnaire developed by the EORTC, applicable to all cancer patients. Scores are standardized to a 0-100 scale. For functional scales and the global quality of life scale, higher scores indicate better functioning or quality of life. For symptom scales/single items, higher scores indicate more severe symptoms or problems. EORTC QLQ-EN24: This is a module specifically designed to assess symptoms and quality of life unique to endometrial cancer patients. It serves as a supplementary module to the QLQ-C30 and cannot be analyzed independently. Scores are standardized to a 0-100 scale. For symptom items, higher scores indicate a greater symptom burden. For function/satisfaction items, higher scores indicate better function or satisfaction.
Time frame: From date of surgery to the 3 years after treatment initiation
Treatment Costs
Time frame: Through radiotherapy completion, an average of 1 month.
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