NL-OMON36646已完成2 期
Feasibility study of adjuvant laparoscopic hyperthermic intraperitoneal chemotherapy in patients with colorectal cancer at high risk of peritoneal carcinomatosis - Lap. HIPEC study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients diagnosed with adenocarcinoma of the colon and proximal rectum and at least one of the following risk factors for PC will be considered for inclusion:
- •* (Resected) local peritoneal nodules in the close proximity of the primary tumour
- •* Primary tumour presenting with obstruction and/or perforation
- •* Positivie cytology in peritoneal lavage
- •* Ovarian metastasis or omental metastasis;Eligibility criteria are:
- •* age between 18 and 75 years,
- •* ECOG performance status 0 to 2,
- •* written informed consent obtained prior to any study specific screening procedures,
- •* white blood cell count at least 3000/mm3, platelet count at least 100.000/mm3,
- •* no bleeding diathesis or coagulopathy,
- •* creatinine normal or creatinine clearance at least 50 ml/min
排除标准
- •* liver and/or lung metastases,
- •* pregnant or lactating women,
- •* unstable or uncompensated respiratory or cardiac disease,
- •* serious active infections,
- •* other concurrent chemotherapy.
研究者
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