NCT01226550已完成1 期
Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Morbidity rate
研究概览
简要总结
This is an open, non-randomized, phase I-II, pilot study, which evaluates the combination of optimum cytoreductive surgery and hyperthermic intraoperative peritoneal chemotherapy (HIPEC) with mitomycin C (MMC) and irinotecan. The latter drug will be administered in escalating doses to patients with gastric, colorectal, appendicular, or primary peritoneal carcinosis (PC).
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a peritoneal carcinosis (PC) either of digestive origin or primary: a colorectal or gastric carcinosis, a peritoneal pseudomyxoma or mesothelioma, or a primary carcinosis of the peritoneum regardless the number of prior treatment lines.
- •A PC and primary tumor considered to be resectable according to preoperative clinical and paraclinical data: absence of mesenteric retraction and absence of bladder invasion.
- •Patients in good general health (ASA ≤ 2).
- •Absence of cardiorespiratory failure (PaO2 > 60 mmHg in a stable condition, dyspnea ≤ NYHA stage 1, left ventricular ejection fraction > 60%.).
- •Prothrombin level >70 %, total bilirubin < 2 x the normal level, ASAT and ALAT < 2.5 x normal levels, and alkaline phosphatases < 5 x normal levels.
- •Creatinine clearance > 60 ml/min, polynuclear neutrophils > 1500/mm3, and a white blood cell count > 4000 /mm
- •Patients who give written, informed consent.
- •Patients affiliated with the French universal healthcare system.
排除标准
- •Patients with a PC with ovarian, mammary, biliary, pancreatic, or bronchial origin.
- •Evolutive patients after systemic chemotherapy.
- •Patients with a PC considered to be irresectable according to preoperative clinical and paraclinical data: mesenteric retraction or bladder invasion.
- •Patients in poor general health (ASA > 2).
- •Cardiorespiratory failure (dyspnea > NYHA stage 1, PaO2 < 60 mmHg in a stable condition)
- •Prothrombin level < 70 %.
- •Any brain abnormality showing on the head scan.
- •Signs of heart failure and especially left ventricular ejection fraction < 60% on the cardiac ultrasound.
- •Thrombocytopenia < 100 000 / mm3
- •Visceral metastases other than a single resectable liver metastasis.
- •Pregnancy or breast feeding.
- •Chronic inflammatory intestinal disease and/or an intestinal obstruction.
- •History of severe hypersensitivity to irinotecan hydrochloride trihydrate or one of the excipients of Campto.
- •Bilirubinemia > 3 times the normal upper limit
- •Yellow fever vaccine.
- •Prophylactic treatment with phenytoin.
- •Severe medullary insufficiency.
结局指标
主要结局
Morbidity rate
时间窗: 30 days postoperative
postoperative complications (class III and IV, Common Terminology Criteria V3; National Cancer Institute)
次要结局
- Mortality rate(30 days postoperative)
- Intraperitoneal and serumal concentration (pharmacokinetics) of mitomycine C, irinotecan, and its metabolites.(per-HIPEC)
研究者
研究点 (2)
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