Combination Chemotherapy of Paclitaxel and Carboplatin With or Without Anthracycline as an Adjuvant Treatment in Endometrial Carcinoma

Study Overview
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Brief Summary
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Endometrial cancer, the most common gynecologic cancer worldwide, is steadily increasing in developed countries.The early-stage forms of endometrial cancer are usually highly curable by surgical treatment alone, whereas advanced stages require adjuvant interdictions such as radiotherapy and chemotherapy. Platinum and anthracycline drugs have long been used as standard adjuvant chemotherapy drugs for advanced and recurrent endometrial carcinomas. In one study, the standard combination adjuvant treatment with AP was found to be more effective as an adjuvant therapy than whole abdominal irradiation

Official Title
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Combination Chemotherapy of Paclitaxel and Carboplatin With or Without Anthracycline as an Adjuvant Treatment in Endometrial Carcinoma

Conditions
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Endometrial Carcinoma

Intervention / Treatment
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* Drug: Paclitaxel/epirubcin/carboplatin
* Drug: Paclitaxel/carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:• Age group: Histologically diagnosed with primary endometrial carcinoma more than 20 years old. Any histological type of endometrial carcinoma Stage III, IV Stage one I or II with one or more of the following factors: Histologic grade 3 endometroid carcinoma with myometrial invasion still within half of the myometrium histological grade 1,2 endometroid carcinomas with invasion of over half of myometrium cervical stromal invasion vascular invasion; or serous carcinoma, clear cell carcinoma, or undifferentiated carcinoma performance status 0-2 adequate function of all major organs Exclusion Criteria: • Pt has received prior radiation or chemotherapy. Pt with sarcomatous component Metastatic endometrial carcinoma Other malignancy Unfit patient for chemotherapy

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: group A<br>will receive the TEC regimen: paclitaxel 150mg/m2 infused for 3 hours, epirubicin 50mg/m2 infused for 30 minutes, and carboplatin 4mg/ml/min for one hour on day 1 every 3 weeks. | Drug: Paclitaxel/epirubcin/carboplatin<br>* adjuvant treatment in endometrial carcinoma<br>|
| Active Comparator: group B<br>) will receive a ddTC regimen: paclitaxel 80mg/m2 for 3 hours on day 1,8,15. Carboplatin AUC 5 over one hour on day 1 repeated at 3-week intervals | Drug: Paclitaxel/carboplatin<br>* Dose dense paclitaxel/carboplatin<br>|
| Active Comparator: group C<br>: paclitaxel 175 mg/m2 over 3 hours infusion on day 1-carboplatin AUC 5 over 1 hour on day 1 at 3 weeks intervals | Drug: Paclitaxel/carboplatin<br>* Dose dense paclitaxel/carboplatin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion rate of chemotherapy | 6 cycles | 6 months |