Combination Chemotherapy of Paclitaxel and Carboplatin With or Without Anthracycline as Aneo Adjuvant Treatment in Advanced Endometrial Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Completion rate of chemotherapy
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •• Pt has received prior radiation or chemotherapy.
- •Pt with sarcomatous component
- •Metastatic endometrial carcinoma
- •Other malignancy
- •Unfit patient for chemotherapy
研究组 & 干预措施
group C
: paclitaxel 175 mg/m2 over 3 hours infusion on day 1-carboplatin AUC 5 over 1 hour on day 1 at 3 weeks intervals
干预措施: Paclitaxel/carboplatin (Drug)
group A
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.
干预措施: Paclitaxel/epirubcin/carboplatin (Drug)
group B
) 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
干预措施: Paclitaxel/carboplatin (Drug)
结局指标
主要结局
Completion rate of chemotherapy
时间窗: 6 months
6 cycles
次要结局
未报告次要终点
研究者
Asmaa Gamal Mahmoud
assistant lecteurer oncology department sohag univerisity hospital
Sohag University