Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Location status: Recruiting
NCT Number: NCT07116213
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.
Interested in participating?
Request Info18 year–70 year
Female
Interventional
Not applicable
Beijing, Beijing Municipality, 100730, China
Location status: Recruiting
Research Process
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
ECOG score 0-2.
Total hysterectomy and bilateral salpingo-oophorectomy ± Pelvic and/or para-aortic lymph node dissection/sampling or sentinel lymph node biopsy.
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.
Exclusion criteria
Without adjuvant chemotherapy: >12 weeks between surgery and radiotherapy initiation.
With adjuvant chemotherapy: >6 months between surgery and radiotherapy initiation.
Moderately Hypofractionated Adaptive Postoperative Radiotherapy
Time frame: <90 days after treatment initiation
Toxicities occurring <90 days from radiotherapy initiation. Evaluated using CTCAE v5.0.
Time frame: From date of surgery to the 3 years after treatment initiation
The time from treatment initiation until the occurrence of any treatment failure events.
Time frame: ≥90 days after treatment initiation
Toxicities occurring ≥90 days from radiotherapy initiation. Evaluated using the RTOG Late Morbidity Scoring Schema.
Time frame: 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.
Time frame: Through radiotherapy completion, an average of 1 month.
Contact information is provided by the study sponsor or research team.
Xiaorong Hou, Professor
CONTACT
Zihan Yan
CONTACT
Xiaorong Hou
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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