Secondary Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Platinum-sensitive Recurrent Epithelial Ovarian Cancer Patients - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Complete resection rate
研究概览
简要总结
About 80% of advanced ovarian cancer patients recurred in 2-3 years. Secondary cytoreduction benefits selected patients who have high chance of complete resection. Whether secondary interval surgery can be used at recurrence is not known.
详细描述
Our study aims to evaluate the complete resection rate at interval cytoreductive surgery for recurrent ovarian cancer patients, and to determine the safety and survival outcomes of this approach.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically diagnosed EOC, fallopian tube or primary peritoneal carcinoma
- •>= 3 cycles of platinum-based chemotherapy, with or without bevacizumab and / or PARPi, at primary setting
- •Platinum-free interval should be >=6 months from the last dose of platinum-based chemotherapy
- •Upfront SCR not feasible
- •Patients should have Eastern Cooperative Oncology Group (ECOG) performance score 0 to 2 within 28 days prior to recruitment.
- •Patients must have adequate bone marrow, renal, hepatic and neurological function within 28 days prior to the start of treatment.
排除标准
- •Non-epithelial or borderline tumors are excluded
- •Patients who have with concurrent malignancy within five years (except for basal or squamous cell skin cancer, in-situ breast cancer, stage 1a grade 1-2 endometrioid endometrial carcinoma without lymphovascular invasion) are excluded.
- •Patients using more than one line of chemotherapy are excluded.
- •Patients who have platinum-resistant or refractory recurrence are excluded.
- •Patients having second relapse or beyond are excluded.
- •Patients who have contraindications to operation, e.g., unresolved thrombocytopenia, bowel obstruction in the last 4 weeks prior to enrolment
研究组 & 干预措施
Chemotherapy and surgery arm
Patients receive platinum-based chemotherapy with or without bevacizumab, and then undergo cytoreductive operation, for the first recurrence of EOC.
干预措施: Carboplatin or cisplatin (Procedure)
Chemotherapy and surgery arm
Patients receive platinum-based chemotherapy with or without bevacizumab, and then undergo cytoreductive operation, for the first recurrence of EOC.
干预措施: Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar (Drug)
Chemotherapy and surgery arm
Patients receive platinum-based chemotherapy with or without bevacizumab, and then undergo cytoreductive operation, for the first recurrence of EOC.
干预措施: Bevacizumab or biosimilar (Drug)
Chemotherapy and surgery arm
Patients receive platinum-based chemotherapy with or without bevacizumab, and then undergo cytoreductive operation, for the first recurrence of EOC.
干预措施: Cytoreductive surgery (Procedure)
结局指标
主要结局
Complete resection rate
时间窗: 12 months
Rate of complete resection at the time of operation
次要结局
- 12-month progression-free survival rate(12 months)
- 12-month overall survival rate(12 months)
- Quality of life scale(12 months)
- Surgical complication rate(12 months)
研究者
Dr. Ka-Yu Tse
Clinical Associate Professor
The University of Hong Kong