NCT05607329招募中不适用
Secondary Cytoreduction Followed by Chemotherapy Versus Chemotherapy Alone in Relapsed Ovarian Cancer After PARPi Maintenance Treatment: a Multicenter, Open-label, Randomized, Phase 3 Trial
Women's Hospital School Of Medicine Zhejiang University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- progression free survival (PFS)
研究概览
简要总结
This study aims to carry out a multi-center, randomized controlled study on patients with recurrent ovarian cancer after PARPi maintenance, to explore the clinicopathological and molecular characteristics of patients with recurrent ovarian cancer after PARPi maintenance, and to clarify whether patients with recurrent ovarian cancer after PARPi maintenance for more than 6 months are sensitive to platinum drugs, and the value of secondary tumor cell reduction in such treatment, In order to provide evidence-based medicine basis for the standardized treatment mode of recurrent ovarian cancer after PARPi maintenance treatment.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of first-line or second-line recurrent epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma, who has previously received at least 4 cycles of platinum-based chemotherapy in initial treatment;
- •Relapse occurred after 6 month since platinum-based chemotherapy;
- •PARPi maintenance therapy for more than 6 months before relapse;
- •R0 ideal debulking in initial surgery;
- •PET-CT indicate the recurrence lesion is isolated and not exceed 5 sites, and the ascites is less than 500ml;
- •ECOG/WHO Performance score of 0 to 1;
- •No hepatic failure, bilirubin ≤ 1,5 time the Normal limit, ASAT and ALAT ≤ 3 time the Upper Normal Limit
- •No Renal insufficiency (serum creatinine < 1,5 time the normal limit, creatinine clearance > 80 mL/min). calculated with MDRD method
- •Hematology function: PNN ≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L
- •No contraindication to general anaesthesia for heavy surgery
- •Patients having read, signed and dated Informed consent before any study procedure
排除标准
- •Platinum-refractory/uncontrolled epithelial ovarian cancer;
- •Non-epithelial ovarian tumor, mucinous, serous-mucinous (mainly mucinous), malignant Brenner tumor, low-grade serous carcinoma, borderline tumor;
- •Suffering from other malignant tumors that have not achieved complete remission in the past 2 years;
- •Received radiotherapy within 2 weeks before the start of the study intervention;
- •General conditions cannot tolerate secondary cytoreduction;
- •Severe hypersensitivity reactions (≥ grade 3) to paclitaxel or platinum and/or any of its excipients.
研究组 & 干预措施
Secondary cytoreduction followed by chemotherapy
Experimental
干预措施: Secondary cytoreduction (Procedure)
Secondary cytoreduction followed by chemotherapy
Experimental
干预措施: Chemotherapy (Drug)
chemotherapy alone
Active Comparator
干预措施: Chemotherapy (Drug)
结局指标
主要结局
progression free survival (PFS)
时间窗: 18-24 months
progression free survival
次要结局
未报告次要终点
研究者
研究点 (1)
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