NCT05633199尚未招募不适用
Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer：a Randomized Controlled Study
Women's Hospital School Of Medicine Zhejiang University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This novel study was specifically designed for platinum-resistant recurrent ovarian cancers with PFI<6 months and aimed to compare prognosis of patients who received cytoreductive surgery followed by chemotherapy versus chemotherapy alone.
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
- Single (Participant)
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 epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma within 3 lines recurrence;
- •Recurrence occurred within 6 months since platinum-based chemotherapy;
- •R0 ideal debulking in initial surgery; PET-CT indicate the recurrence lesion is almost in abdominal cavity, which is isolated and not exceed 5 sites, and the ascites is less than 500ml;
- •ECOG/WHO Performance score of 0 to 1;
- •Hematology function: Leukocyte≥ 3,5x10⁹/L, neutrophil≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L;
- •No Renal insufficiency: serum creatinine < 1,5 time the normal limit, creatinine clearance > 60 mL/min;
- •No hepatic failure: bilirubin ≤ 1,5 time the Normal limit;
- •Patients with good compliance;
- •Patients having read, signed and dated Informed consent before any study procedure.
排除标准
- •Platinum-refractory/uncontrolled epithelial ovarian cancer;
- •Mucous carcinoma or low-grade serous carcinoma;
- •Suffering from other malignant tumors that have not achieved complete remission in the past 2 years;
- •Patients have received abdominal or pelvic radiotherapy;
- •General conditions cannot tolerate cytoreduction;
- •Severe hypersensitivity reactions (≥ grade 3) to paclitaxel or platinum and/or any of its excipients;
- •Unable or unwilling to sign the informed consent form;
- •Patients judged by the investigator to be unlikely to follow the research steps, restrictions and requirements.
结局指标
主要结局
PFS
时间窗: month 6
period from the end of treatment to the recurrence of disease
次要结局
未报告次要终点
研究者
研究点 (1)
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