EUCTR2019-002507-18-FR进行中（未招募）1 期
Efficacy and feasibility of pasireotide to reduce clinically relevant digestive leakage after complete cytoreductive surgery (CRS) plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for peritoneal carcinomatosis – a phase II randomized multicentric trial - PASIREOCHIP
Gustave Roussy0 个研究点目标入组 217 人开始时间: 2019年11月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 217
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
- All
入选标准
- •Male or female patients aged 18 years or greater
- •ECOG (Eastern Cooperative Oncology Group) Performance Status = 2
- •Primary (pseudomyxoma peritonei, peritoneal mesothelioma) or Secondary (colorectal or ovarian) peritoneal malignancies
- •Curative intent resection obtained by a complete resection according to the Completeness of Cytoreduction score (CC) (CC 0-1) followed by HIPEC
- •Different intraperitoneal drug administration modalities such as neoadjuvant systemic plus simultaneous intraperitoneal and intravenous chemotherapy (NIPS) or pressurized intra-peritoneal aerosol chemotherapy (PIPAC) does not represent exclusion criteria.
- •Absence of extra-peritoneal metastatic disease or limited hepatic or lung metastases easily amenable to curative-intent resection or ablation
- •Intraoperative Peritoneal Cancer Index (PCI score) = 10
- •Visceral resection with at least one digestive anastomosis with or without loop ileostomy or pancreatic or biliary resection
- •Negative serum pregnancy test for women of childbearing potential within 7 days prior to therapy
- •Sexually active women of childbearing potential must agree to use a highly effective method of contraception or to abstain from sexual activity during the study and for 3 months after the last study treatment administration. Sexually active males patients must agree to use condom or to abstain from sexual activity during the study and for 3 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception
- •Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
- •Patients must be affiliated to a social security system or beneficiary of the same
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 163
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
排除标准
- •Macroscopically incomplete surgical resection (CC 2)
- •Standard contraindications to pasireotide:
- •-patients with uncontrolled diabetes mellitus or a fasting plasma glucose > 250mg/dl (14 mMol/L)
- •-patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia including a corrected QT (QTc) interval longer than 450 msec, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment
- •-patients with liver disease such as severe hepatic impairment (Child Pugh C), chronic active hepatitis or chronic persistent hepatitis with abnormal coagulation (INR>1.5).
- •-patients with the presence of active or suspected acute or chronic uncontrolled infection
- •-hypersensitivity to somatostatin analogues or any component of pasireotide formulations
- •-patients with uncontrolled hypothyroidism
- •Patients participating or who have participated to another study evaluating the effect of a new drug other than pasireotide within 1 month prior to dosing
- •Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study.
- •Women who are pregnant or likely to be so, or who are breastfeeding
- •Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
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