A Phase II Trial of Docetaxel / Cisplatin in Patients With Recurrent or Stage IVb Endometrial Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
The purpose of this study is to treat advanced or recurrent endometrial cancer, paclitaxel-containing regimen is the preferred chemotherapeutic regimen which is selected by most physicians. Docetaxel may have similar efficacy and more favorable treatment related toxicity profile as tested in epithelial ovarian cancer trials. Therefore, the investigators aimed to evaluate the efficacy and safety of docetaxel plus cisplatin in patients with advanced or recurrent 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
- •Histologically confirmed chemotherapy naïve endometrial cancer
- •One of following histology Endometrioid, UPSC, CCCa, squamous, adenosquamous, mixed
- •FIGO stage IVb or recurrent endometrial cancer (incurable by surgery and/or RT)
- •At least one measurable lesion by RECIST on CT
- •ECOG PS: 0-2
- •Age: 20-75
- •Adequate organ function BM: ANC≥1,000/mm3, Plt≥100X103/mm3 Kidney: Creatinine<1.25 × UNL이고, GFR ≥ 60 Liver: AST, ALT< 3×UNL, T- bil<1.5 mg/ mm3
- •Informed Consent
- •Contraception during study period
排除标准
- •Previous chemotherapy
- •RT, hormone therapy, or immunotherapy within 1 month
- •Other malignant disease
- •Uncontrolled medical disease
- •Infection requiring antibiotics
- •Symptomatic CHF, RF, Angina, Arrhythmia, etc.
- •Neurosis or psychosis
- •Pregnancy, breast-feeding
研究组 & 干预措施
Chemotherapy
Docetaxel 70mg/m2BSA + Cisplatin 60mg/m2BSA, q 3 weeks, 8cycles
干预措施: Doctaxel (Drug)
Chemotherapy
Docetaxel 70mg/m2BSA + Cisplatin 60mg/m2BSA, q 3 weeks, 8cycles
干预措施: Cisplatin (Drug)
结局指标
主要结局
Response rate
时间窗: 3 months after completion of study treatment
次要结局
- Progression-free survival(2 years 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)
- Quality of life(3 months after completion of study treatment)
研究者
Joo-Hyun Nam
Professor
Asan Medical Center