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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VBT | Experimental | CT image guided high-dose-rate vaginal brachytherapy, 30Gy/6f, 2f/w. |
|
| EBRT | Active Comparator | Pelvic external beam radiotherapy,IMRT/VAMT,IGRT suggested,DT 45Gy/25f. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vaginal brachytherapy/pelvic external beam radiotherapy | Radiation | high-dose-rate vaginal brachytherapy; pelvic external beam radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| DFS | disease-free survival from being received treatment | 5-year |
| Measure | Description | Time Frame |
|---|---|---|
| Failure mode | vaginal recurrences; pelvic recurrence; distant metastases | 5-year |
| OS | Overall survival from being received treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junjie Wang | Contact | 861082265920 | junjiewang_edu@sina.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University 3rd Hospital | Beijing | Beijng | 100191 | China |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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|
| 5-year |
| Toxicities | from being received treatment | 5-year |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |