EUCTR2015-000418-23-BE进行中（未招募）1 期
Intraoperative intraperitoneal chemoperfusion to treat peritoneal minimal residual disease in stage III ovarian cancer: a randomized phase II trial.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •?Tumor type
- •oBiopsy proven serous epithelial ovarian carcinoma or peritoneal carcinoma
- •?Primary or recurrent disease
- •?Extent of disease
- •oPositive retroperitoneal lymph nodes and /or microscopic metastasis beyond the pelvis (FIGO stage III)
- •oStage IV with unilateral pleural fluid allowed
- •oComplete or nearly complete macroscopic cytoreduction at the time of surgery (CC-0 or CC-1) deemed possible based on imaging, laparoscopy, or both
- •?Second-line patients; platinum sensitive
- •?Age over 18 years
- •?No major cardiac or respiratory disease
- •?Absent or limited (<500ml) clinical ascites
- •?Adequate performance status (Karnofsky index > 70%)
- •?Adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent
- •?Expected life expectancy more than 6 months
- •?Laboratory data
- •oSerum creatinine ? 1.5 mg/dl or a calculated GFR (CKD-EPI) = 60 mL/min/1.73 m2
- •oSerum total bilirubin ? 1.5 mg/dl, except for known Gilbert’s disease
- •oPlatelet count > 100.000/µl
- •oHemoglobin > 9g/dl
- •oNeutrophil granulocytes > 1.500/ml
- •oInternational Normalized Ratio (INR) ? 2
- •?Absence of alcohol and/or drug abuse
- •?No other concurrent malignant disease
- •?No inclusion in other clinical trials interfering with the study protocol
- •?No concurrent chronic systemic immune or hormone therapy, except neoadjuvant chemotherapy
- •?Absence of any severe organ insufficiency
- •?No pregnancy or breast feeding
- •?Written informed consent
- •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 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •?Severe or uncontrolled cardiac insufficiency, including recent (< 6 months) occurrence of myocardial infarction, the presence of congestive cardiac insufficiency, of symptomatic angor in spite of optimal medical care, of cardiac arrhythmia requiring medical treatment presenting insufficient rhythm control, or uncontrolled arterial hypertension
- •?Pregnancy or breast feeding
- •?Platinum resistant (relapse > 12 months after completion of Pt containing therapy) or refractory disease
- •?Active bacterial, viral or fungal infection
- •?Active gastro-duodenal ulcer
- •?Parenchymal liver disease (any stage cirrhosis)
- •?Uncontrolled diabetes mellitus
- •?Severe obstructive or restrictive respiratory insufficiency
- •?Psychiatric pathology capable of affecting comprehension and judgment faculty
- •?Tumor in the presence of obstruction
- •?Evidence of extra-abdominal disease (with the exception of unilateral malignant pleural effusion) or extensive liver metastasis
- •?Peritoneal cancer index (sPCI) = 25
研究者
相似试验
已完成
不适用
Peri-operative chemotherapy with intraperitoneal and intravenous Paclitaxel plus TS-1 for serosa positive gastric cancer patientsserosa positive gastric cancerJPRN-UMIN000013109Intraperitoneal chemotherapy study group50
尚未招募
2 期
Determining the efficacy and safety of neoadjuvant IP chemotherapy in rectal cancer patients with the spread of disease in peritoneumCTRI/2023/11/059575Tata Memorial Hospital
招募中
不适用
Concomitant intraperitoneal and systemic chemotherapy in patients with extensive peritoneal carcinomatosis of gastric origiNL-OMON51789Erasmus MC, Universitair Medisch Centrum Rotterdam54
已完成
不适用
Concomitant intraperitoneal and systemic chemotherapy in patients with extensive peritoneal carcinomatosis of colorectal origiNL-OMON50387Erasmus MC, Universitair Medisch Centrum Rotterdam33
进行中（未招募）
1 期
Catheter based adjuvant intraperitoneal chemotherapy for carcinomatosis.carcinomatosisMedDRA version: 17.0Level: LLTClassification code 10007506Term: CarcinomatosisSystem Organ Class: 100000004864EUCTR2014-000882-34-BEniversity Hospital Ghent24