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| Name | Class |
|---|---|
| Shandong University | OTHER |
| Huazhong University of Science and Technology | OTHER |
| Zhejiang University | OTHER |
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This randomized trial is studying the efficacy and safety of the chemotherapy compared with radiation therapy alone as adjuvant treatment after operation in Patients with high risk and Stage I endometrial carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant Chemotherapy | Experimental | Paclitaxel: 175 mg/m(2) intravenously (IV); followed by Paraplatin (Carboplatin Injection) AUC=5 IV. 3-6 cycles as necessary. |
|
| Adjuvant Radiotherapy | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | 175 mg/m(2), intravenously (IV) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | 3-year DFS |
| Measure | Description | Time Frame |
|---|---|---|
| Side effect of adjuvant chemotherapy | The incidence of infusion reactions (i.e.,skin reactions, cardiovascular reactions, respiratory or throat tightness), and allergic reactions (i.e., life-threatening anaphylaxis) | 3-month，6-month，1-year and 3-year |
| Complications of radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beihua Kong, MD, PhD | Qilu Hospital of Shandong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China | ||
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| Paraplatin (Carboplatin Injection) |
| Drug |
AUC=5, IV |
|
| Pelvic Radiation | Radiation | 45-50 Gy |
|
| Vaginal Brachytherapy 1 | Radiation | 5 Gy, 3 times |
|
| Vaginal brachytherapy 2 | Radiation | 5 Gy, 2-4 times |
|
To observe the subtle effect on quality of life (e.g., diarrhea, bowel symptoms) and vaginal stenosis. |
| 3-month，6-month，1-year and 3-year |
| Quality of Life | 3-month，6-month，1-year and 3-year |
| Overall survival (OS) | 3-year OS |
| Qilu Hospital，Shandong University |
| Jinan |
| Shandong |
| 250012 |
| China |
| Women's Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310006 | China |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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