The Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Prospective, Randomized Trial of the Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma

Conditions
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Endometrial Neoplasms

Intervention / Treatment
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* Drug: Paclitaxel
* Drug: Paraplatin (Carboplatin Injection)
* Radiation: Pelvic Radiation
* Radiation: Vaginal Brachytherapy 1
* Radiation: Vaginal brachytherapy 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: FIGO stage: Ⅰ, endometrial carcinoma; Female, Chinese women; Initial treatment is staging surgery; Pathological diagnosis: Endometrial adenocarcinoma; Pathologic examination and meet the following one of the indications of adjuvant therapy: ① histopathological grading in poorly differentiated: G3; ② ≥50% myometrial invasion; ③ vascular space involvement; No prior treatment; Provide written informed consent. Exclusion Criteria: Unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy; Family history of ovarian cancer; Suffering from other malignancies; Concurrently participating in other clinical trials; Unable or unwilling to sign informed consents; Unable or unwilling to abide by protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Adjuvant Chemotherapy<br>Paclitaxel: 175 mg/m(2) intravenously (IV); followed by Paraplatin (Carboplatin Injection) AUC=5 IV. 3-6 cycles as necessary. | Drug: Paclitaxel<br>* 175 mg/m(2), intravenously (IV)<br>Drug: Paraplatin (Carboplatin Injection)<br>* AUC=5, IV<br>|
| Active Comparator: Adjuvant Radiotherapy<br>Histopathological grade G3 and <50% myometrial invasion: Vaginal brachytherapy 5Gy, 3 times; Histopathological grade G3 and vascular space involvement: Pelvic radiation 45-50 Gy; ≥50% myometrial invasion: Pelvic radiation 50 Gy + Vaginal brachytherapy 5Gy, 2-4 times. | Radiation: Pelvic Radiation<br>* 45-50 Gy<br>Radiation: Vaginal Brachytherapy 1<br>* 5 Gy, 3 times<br>Radiation: Vaginal brachytherapy 2<br>* 5 Gy, 2-4 times<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival (DFS) |  | 3-year DFS | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |