EUCTR2012-002872-15-IT进行中（未招募）不适用
Hyperthermic intra-peritoneal chemotherapy (HIPEC) in Ovarian cancer recurrence: Randomized trial on Survival Evaluation. - MITO 18
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 个研究点开始时间: 2012年9月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •-Age over 18 and under 70 years
- •-Patients affected by a first recurrence of ovarian cancer with measurable or not measurable lesions, but evaluable (upwards of Ca125 for 2 consecutive assessments).
- •-ECOG-performance status = 2
- •-Ovarian cancer limited to the abdominal cavity with or without extraperitoneal spread considered resectable at intraoperative evaluation
- •-Evidence of tumor recurrence diagnosed after 6 months from primary treatment
- •-Previous-based chemotherapy of carboplatin and taxanes
- •-Peritoneal Washing-positive in the presence of other abdominal disease surgically resectable
- •-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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
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 active infection or other neoplastic disease in progress
- •-Patients with bowel obstruction
- •-Inadequate bone marrow, liver, kidney function
- •-No clear-peritoneal disease at surgical exploration
- •-Patients with ascites> 500 ml (the TAC)
- •-Patients on maintenance therapy with Antiangiogenic
- •-Patients with secondary or tertiary recurrence, or already submitted to HIPEC
- •-Patients who have already made the second or third line chemotherapy.
研究者
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