Clinical Research on Moderately Hypofractionated Adaptive Postoperative Radiotherapy for High-Risk Endometrial Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorXiaorong Hou
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age : 18-70 years old.
Expected to comply with oART (Online Adaptive Radiotherapy) workflow.
Patients and families fully understand the study protocol.
Voluntarily participate and sign informed consent forms before enrollment
Disqualifiers
Prior Radiotherapy : History of abdominal or pelvic irradiation.
Malignancy History : Prior diagnosis of other malignancies.
Pregnancy/Lactation : Pregnant or breastfeeding women.
Active Infection : Fever or uncontrolled active infection.
Trial design
Design model
Single group
Treatments tested in this trial
Moderately Hypofractionated Adaptive Radiotherapy
RadiationModerately Hypofractionated Adaptive Postoperative Radiotherapy
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Moderately Hypofractionated Adaptive RadiotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acute toxicity
Toxicities occurring \<90 days from radiotherapy initiation. Evaluated using CTCAE v5.0.
Time frame
<90 days after treatment initiationSecondary outcomes
1
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 initiation2
Chronic Toxicity
Toxicities occurring ≥90 days from radiotherapy initiation. Evaluated using the RTOG Late Morbidity Scoring Schema.
Time frame
≥90 days after treatment initiation3
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 initiation4
Treatment Costs
Time frame
Through radiotherapy completion, an average of 1 month.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Xiaorong Hou
Lead sponsor
Peking Union Medical College Hospital
Sponsor institution
Source ClinicalTrials.gov