Adjuvant Radiotherapy in Patients With Early Endometrial Cancer

Study Overview
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Brief Summary
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To compare the effect of vaginal brachytherapy as adjuvant treatment after operation when compared to pelvic external beam radiotherapy in patients with early endometrial cancer based on moderate risk molecules classification.

Detailed Description
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After being informed the study and potential risk，all patients giving written informed consent will be undergo a 1-week screening period determine eligibility for study entry. At week 0, patients who meet the eligibility will be randomized in a 1:1 ratio to vaginal brachytherapy or pelvic external beam radiotherapy. After treatment, patients were followed up regularly.

Official Title
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A Multicenter, Randomized, Controlled Trial of Adjuvant Radiotherapy in Patients With Early Endometrial Cancer Based on Moderate Risk Molecules Classification

Conditions
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Endometrial Cancer, Pathology, Radiotherapy

Intervention / Treatment
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* Radiation: vaginal brachytherapy/pelvic external beam radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Endometrial adenocarcinoma is confirmed by pathology, and the molecular types were microsatellite instability type and low copy type; Stage IA and grade 3 or stage IB (FIGO 2009), without substantial lymph-vascular space invasion; Surgery must have included a hysterectomy and bilateral adnexectomy. Pelvic lymph node sampling and para-aortic lymph node sampling are optional; ECOG score is 0-2; The interval time between surgery and radiotherapy is no more than 8 weeks; The routine blood examination was normal; Compliance is good and informed consent is voluntarily signed. Exclusion Criteria: The patients receive chemotherapy; History of previous malignant disease; Previous diagnosis of Crohn's disease or ulcerative colitis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VBT<br>CT image guided high-dose-rate vaginal brachytherapy, 30Gy/6f, 2f/w. | Radiation: vaginal brachytherapy/pelvic external beam radiotherapy<br>* high-dose-rate vaginal brachytherapy; pelvic external beam radiotherapy<br>* Other names: Pelvic external beam radiotherapy;|
| Active Comparator: EBRT<br>Pelvic external beam radiotherapy，IMRT/VAMT，IGRT suggested，DT 45Gy/25f. | Radiation: vaginal brachytherapy/pelvic external beam radiotherapy<br>* high-dose-rate vaginal brachytherapy; pelvic external beam radiotherapy<br>* Other names: Pelvic external beam radiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFS | disease-free survival from being received treatment | 5-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure mode | vaginal recurrences; pelvic recurrence; distant metastases | 5-year | 
| OS | Overall survival from being received treatment | 5-year | 
| Toxicities | from being received treatment | 5-year |