Endometrial Cancer, Hypofractionated Dose, Radiotherapy, Adjuvant, Side Effects, Survival , Tumor
Conditions
Keywords
endometrial cancer, Hypofractionated dose, Radiotherapy
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.
Detailed description
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.
Interventions
RADIATIONModerately Hypofractionated Adaptive Radiotherapy
Moderately Hypofractionated Adaptive Postoperative Radiotherapy
Sponsors
Xiaorong Hou
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicity | <90 days after treatment initiation | Toxicities occurring \<90 days from radiotherapy initiation. Evaluated using CTCAE v5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year failure-free survival | From date of surgery to the 3 years after treatment initiation | The time from treatment initiation until the occurrence of any treatment failure events. |
| Chronic Toxicity | ≥90 days after treatment initiation | Toxicities occurring ≥90 days from radiotherapy initiation. Evaluated using the RTOG Late Morbidity Scoring Schema. |
| Quality of Life (EORTC QLQ-C30/EORTC QLQ-EN24) | From date of surgery to the 3 years after treatment initiation | 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. |
| Treatment Costs | Through radiotherapy completion, an average of 1 month. | — |
Countries
China
Contacts
CONTACTXiaorong Hou, Professor
CONTACTZihan Yan
Outcome results
None listed