A Phase II Trial of Docetaxel/Cisplatin Chemotherapy Followed by Pelvic Radiation Therapy in Patients, With High-risk Endometrial Carcinoma After Staging Surgery
试验速览
- 阶段
- 2 期
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
Previous some studies suggested the addition of chemotherapy to radiation therapy after surgery may have survival benefit in patients with high risk endometrial cancer. In addition, docetaxel plus cisplatin regimen may have similar efficacy with paclitaxel plus carboplatin which is currently used in most cases. However, docetaxel plus cisplatin may cause less toxicity compared to paclitaxel plus carboplatin. Therefore, the investigators aimed to analyze the efficacy of docetaxel plus cisplatin regimen followed by radiation therapy after surgery in patients with high risk endometrial cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •One of following high risk groups Stage III after staging operation Stage II (Type I hysterectomy + BSO + LND) Stage I + two of [Grade III, LVSI+, Mm>1/2] Clear cell or serous carcinoma: stage IB-II
- •Age: 20-75
- •ECOG PS: 0-2
- •Adequate organ function BM: WBC ≥ 3,000/mm3, ANC≥1,500/mm3, Plt≥100X103/mm3, Hb≥10.0 g/dl Kidney: Creatinine <1.25 × UNL이고, GFR ≥ 60 Liver: AST, ALT< 3×UNL, T- bil<1.5 mg/ mm3
- •Informed Consent
排除标准
- •Previous chemotherapy or pelvic RT
- •Hormone therapy within 4 weeks
- •Other malignant disease
- •Uncontrolled medical disease
- •Infection requiring antibiotics
- •Symptomatic CHF, RF, Angina, Arrhythmia, etc.
- •Neurosis or psychosis
研究组 & 干预措施
Chemotherpay and radiation therapy
Docetaxel plus cisplatin followed by radiation therapy
干预措施: Docetaxel (Drug)
Chemotherpay and radiation therapy
Docetaxel plus cisplatin followed by radiation therapy
干预措施: Cisplatin (Drug)
Chemotherpay and radiation therapy
Docetaxel plus cisplatin followed by radiation therapy
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Progression-free survival
时间窗: 2 years after completion of study treatment
次要结局
- Overall survival(2 years after completion of study treatment)
- Quality of life(3 months after completion of study treatment)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Before each chemotherapy, an expected average of 3 weeks)
研究者
Joo-Hyun Nam
Professor
Asan Medical Center