Phase II Trial of Docetaxel and Carboplatin as Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
Neoadjuvant chemotherapy is alternative treatment option to upfront cytoreductive surgery to treat advanced ovarian cancer. Paclitaxel plus carboplatin is most frequently selected chemotherapeutic regimen for neoadjuvant chemotherapy. Docetaxel had similar therapeutic efficacy compared to paclitaxel in adjuvant chemotherapy trials in ovarian cancer. However, docetaxel had more favorable toxicity profile. Therefore, the investigators aimed to evaluate the efficacy of docetaxel plus carboplatin as neoadjuvant chemotherapy in patients with advanced ovarian 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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Advanced epithelial, tubal, or primary peritoneal cancer
- •Cancer cells in paracentesis, thoracentesis, or laparoscopic surgery
- •Less probability of complete cytoreduction
- •Age: 20-80 years
- •GOG performance status: 0-3
- •Adequate organ function Bone marrow: ANC ≥ 1,500mm3, Platelet ≥ 100,000/mm3, Hb ≥ 10.0 g/dl Kidney: Creatinine ≤ 1.25 × UNL Liver: AST, ALT ≤ × 2.5 UNL (in case of liver metastasis, AST, ALT ≤ × 5 UNL), alkaline phosphatase ≤ 5 x UNL, bilirubin ≤ 1.5 mg/ mm3
排除标准
- •Previous chemotherapy or pelvic radiation therapy
- •Final diagnosis is other malignancies
- •Coincidental Other malignancies within 5 years except carcinoma in situ of uterine cervix
- •History of severe allergy
- •Pregnancy, lactating woman
- •Uncontrolled medial disease
- •Bowel obstruction requiring immediate surgery
研究组 & 干预措施
Chemotherapy
Neoadjuvant chemotherapy with docetaxel plus carboplatin
干预措施: Neoadjuvant chemotherapy (Drug)
Chemotherapy
Neoadjuvant chemotherapy with docetaxel plus carboplatin
干预措施: Carboplatin (Drug)
结局指标
主要结局
Response rate
时间窗: 1 month after completion of study treatment
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Before each chemotherapy, an average of 3 week)
- Disease-free survival(2 years after completion of study treatment)
- Overall survival(2 years after completion of study treatment)
- The number of participants who achieved optimal cytoreduction(1 month after completion of study treatment)
研究者
Jong-Hyeok Kim
Professor
Asan Medical Center