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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2030-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Endometrial Cancer Hypofractionated Dose Radiotherapy, Adjuvant Side Effects Survival , Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Moderately Hypofractionated Adaptive Radiotherapy

Group Type EXPERIMENTAL

Moderately Hypofractionated Adaptive Radiotherapy

Intervention Type RADIATION

Moderately Hypofractionated Adaptive Postoperative Radiotherapy

Interventions

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Moderately Hypofractionated Adaptive Radiotherapy

Moderately Hypofractionated Adaptive Postoperative Radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No