Clinical Outcomes of Secondary Cytoreductive Surgery in Platinum-resistant Ovarian Cancers With Isolated Recurrence
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- progression free survival (PFS)
研究概览
简要总结
This novel study was specifically designed for platinum resistant recurrent ovarian cancers and aimed to compare cases who received secondary cytoreductive surgery for isolated recurrence and chemotherapy versus chemotherapy alone. This comparison will conduct the intraoperative events, postoperative morbidity and mortality, pathological outcomes and long-term oncological outcomes as regarding progression free survival and overall survival rates.
详细描述
Baseline postoperative imaging with the use of abdominopelvic CT or MRI was to be completed during a 28-day window in which chemotherapy was initiated. Disease is also assessed after cycles 3 and 6 of trial treatment (and after cycle 8, if administered), every 3 months for 2 years, and then every 6 months thereafter. Physical examinations will be performed, and serum CA-125 levels measured at the beginning of each cycle of chemotherapy. Treatment-free interval (6 to 12 months or >12 months after the last chemotherapy infusion) will be reported.
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
- •platinum-resistant, recurrent epithelial ovarian cancer
- •amenable to complete gross resection, isolated recurrence
- •adequate renal, hepatic, and bone marrow function,
- •performance-status ECOG score of 0 to 2.
排除标准
- •not medically fit for surgery
- •diffuse carcinomatosis, ascites, or extra-abdominal disease
研究组 & 干预措施
chemotherapy alone
second line chemotherapy according to investigator's choice
干预措施: Chemotherapy (Drug)
surgery + chemotherapy
surgical resection for recurrent platinum resistant ovarian cancer followed by second line chemotherapy as per the investigator's choice
干预措施: secondary cytoreductive surgery (Procedure)
surgery + chemotherapy
surgical resection for recurrent platinum resistant ovarian cancer followed by second line chemotherapy as per the investigator's choice
干预措施: Chemotherapy (Drug)
结局指标
主要结局
progression free survival (PFS)
时间窗: 6 months from enrollment
the time interval between the first relapse and the second relapse
次要结局
- Adverse events (AE)(6 months from enrollment)
- Overall survival (OS)(18 months from enrollment)
研究者
Ahmed Sohaib
Principal investigator, Lecturer of Clinical oncology
Menoufia University