NCT01669226已完成2 期
A Phase II,Randomized Study of an Addition Intraperitoneal Cisplatin and Etoposide to Standard First-line Therapy in Stage IIIC and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC)
Shanghai Gynecologic Oncology Group7 个研究点 分布在 1 个国家目标入组 215 人开始时间: 2009年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 215
- 试验地点
- 7
- 主要终点
- 12-month disease non-progression rate
研究概览
简要总结
The purpose of this study is to evaluate the role of an additional intraperitoneal chemotherapy with cisplatin and etoposide in bulky advanced epithelial ovarian cancer.
详细描述
This exploratory trial is to compare the efficacy of sequential chemotherapy, intraperitoneal chemotherapy followed by intravenous chemotherapy, versus intravenous chemotherapy alone in the first-line therapy for ovarian cancer.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years to ≤ 75 years.
- •Epithelial ovarian cancer with pathology confirmed stage IIIc or IV, expect for lymph node metastasis alone
- •Optimal cytoreductive surgery, including hysterectomy, bilateral salpinges-oophorectomy, omentectomy, and resection of all metastatic lesions, with a residual disease no more than 1cm
- •Available to receive intraperitoneal chemotherapy 5-10 days postoperative, or no more than postoperative 14 days for those with bowel resection.
- •ECOG performance 0-
- •No more than 3 cycles of chemotherapy prior to surgery.
- •Laboratory testing within 7 days of registration: hematopoietic: absolute neutrophil count greater than 1,500/mm3; Platelet count greater than 100,000/mm
- •Hepatic: bilirubin less than 1.25 times upper limit of normal (ULN); Bilirubin < 2.0, SGPT less than 2 times ULN. Renal: creatinine less than 1.6 mg/dL, OR creatinine clearance greater than 40 mL/min.
- •Comply with intraperitoneal chemotherapy and follow-up.
- •Written informed consent.
排除标准
- •Low-malignant potential ovarian tumor.
- •Laboratory testing insufficiency. Hemoglobin < 10 g/dL. Renal insufficiency with serum creatinine > 1.
- •Bone marrow dysfunction: absolute neutrophil count less than 1,500/mm3; Platelet count less than 80,000/mm
- •Active infection.
- •Clinically significant gastrointestinal abnormalities.
- •Active coronary artery disease, cerebrovascular disease, restrictive or obstructive pulmonary disease, or congestive heart failure.
- •Other condition that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
- •Prior invasive malignancies within the last 5 years showing activity of disease.
研究组 & 干预措施
Regimen B, PEip and TCiv therapy
Experimental
Weekly IP cisplatin plus etoposide followed by IV paclitaxel plus carboplatin or docetaxel plus carboplatin
干预措施: PEip (weekly) and TCiv (Drug)
Regimen A: Standard TCiv therapy
Active Comparator
IV paclitaxel plus carboplatin or docetaxel plus carboplatin
干预措施: TCiv (Drug)
结局指标
主要结局
12-month disease non-progression rate
时间窗: 12 months
次要结局
- Quality of life assessments(baseline; 4th week of intraperitoneal,chemotherapy, 6th cycle of intravenous chemotherpy, 3, 6, and 12 months after first-line chemotherapy.)
- Overall Survival(up to 120 months)
- Completion rate of intraperitoneal chemotherapy.(up to 6 months)
- Progression-free survival(up to 120 months)
- adverse effects(Participants will be followed for the duration of hospital stay, an expected average of 5 weeks)
研究者
研究点 (7)
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