Feasibility, Efficacy and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin in Women With Recurrent Ovarian Cancer: an Open-label, Single-arm Phase I-II Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Clinical Benefit Rate (CBR) according to RECIST/GCOG criteria after three cycles of PIPAC with PIPAC cisplatin and doxorubicin
研究概览
简要总结
Patients with first recurrent resistance ovarian cancer and disease progression with peritoneal carcinomatosis will undergo PIPAC procedure. The primary end point is to determine the clinical benefit rate (CBR) of a pressurized intraperitoneal aerosol chemotherapy with a combination of cisplatin and doxorubicin.
详细描述
This study aims to investigate the therapeutic efficacy of PIPAC using cisplatin and doxorubicin in women with first recurrent resistance ovarian cancer and disease progression with peritoneal carcinomatosis. The primary objective of this study is to determine the Clinical Benefit Rate (CBR) according to RECIST/GCOG criteria after three cycles of PIPAC with PIPAC cisplatin and doxorubicin
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients affected by first or second platinum resistant epithelial ovarian tumor recurrence.
- •ECOG-performance status ≤
- •Adequate respiratory, hepatic, cardiac, kidney and bone marrow function (absolute neutrophil count > 1500 / mm3, platelets > 150 000/μl, creatinine clearance > 60 mL / min according to Cockroft formula).
- •Patient-compliant and psychologically able to follow the trial procedures.
排除标准
- •Non-epithelial ovarian cancer or borderline ovarian tumor.
- •Pregnancy or breastfeeding.
- •Patients affected by major depressive disorder even in treatment or minor mood disorders.
- •Patients with severe impairment of respiratory, hepatic or renal function.
- •Patients with cardiac, neurological or metabolic uncontrolled pharmacologically disease
- •Patients with bowel obstruction.
- •Inadequate bone marrow, liver, kidney function.
- •No clear-peritoneal disease at surgical exploration.
- •Patients with ascites >2000 cc (CT-Scan)
- •Patients who have already made third line chemotherapy.
结局指标
主要结局
Clinical Benefit Rate (CBR) according to RECIST/GCOG criteria after three cycles of PIPAC with PIPAC cisplatin and doxorubicin
时间窗: 12-18 weeks
Evaluation of target lesions will be done as follows: * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. * Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase
次要结局
- The proportion of women with a reduction of serum CA-125 of at least 50% after PIPAC(1 Year)
- The degree of histological regression assessed by pathological review of repeated peritoneal biopsies(1 Year)
- The median time to progression according to RECIST criteria after three cycles of PIPAC with cisplatin(1 Year)
- Fagotti score, as assessed by laparoscopy(1 Year)
- Evaluation of the Quality Of Life (QOL) on the basis of the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaires(1 year)
研究者
Prof. Giovanni Scambia
Professor
Catholic University of the Sacred Heart