NL-OMON50387已完成不适用
Concomitant intraperitoneal and systemic chemotherapy in patients with extensive peritoneal carcinomatosis of colorectal origin - INTERACT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
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
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:* Patients with a histologically confirmed diagnosis
- •of colorectal cancer
- •* Radiologically or clinically confirmed diagnosis of peritoneal carcinomatosis
- •* Age * 18 years old
- •* Written informed consent according to the ICH-GCP and national/local
- •regulations
- •* Unknown PCI for which a DLS is planned in the work-up for a HIPEC-procedure
- •OR known PCI >20 evaluated by laparoscopy or laparotomy before inclusion in
- •* Patients must be ambulatory, WHO performance status 0 or 1 (Appendix A
- •* Life expectancy of at least 3 months
- •* Ability to return to the Erasmus MC/Catharina Hospital for adequate follow-up
- •as required by this protocol
- •* Patients must have normal organ function and adequate bone marrow reserve as
- •assessed by the following laboratory requirements:
- •o absolute neutrophil count >1.5 * 10^9/l
- •o platelet count >100*10^9/l
- •o Hb>6.0mmol/l
- •o Bilirubin < 1.5x upper limit of normal (ULN)
- •o Serum AST and ALT < 2.5 x ULN
- •o GFR>45 and Creatinine clearance <2 x ULN
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:* Extra-abdominal disease/metastatic disease
- •established by preoperative CT-scan of thorax-abdomen and/or PET-scan. Imaging
- •not older than 6 weeks at time of surgery
- •* Prior cytoreductive surgery
- •* Prior treatment with systemic chemotherapy for (metastatic) colorectal cancer
- •within the last 6 months
- •* Medical or psychological impediment to probable compliance with the protocol
- •* Serious concomitant disease or active infections
- •* History of auto-immune disease or organ allografts, or with active or chronic
- •infection, including HIV and viral hepatitis
- •* Serious intercurrent chronic or acute illness such as pulmonary (COPD or
- •asthma) or cardiac (NYHA class III or IV) or hepatic disease or other illness
- •considered by the study coordinator to constitute an unwarranted high risk for
- •participation in this study
- •* Homozygous UGT1A1*28 genotype
- •* Homozygous or (compound) heterozygous DPYD genotype (tested for *2A, *13,
- •2846A>T, and 1236G>A)
- •* Current use of strong CYP3A4-inhibitors or inducers. If patients use this
- •CYP3A4-modulating medication, it is allowed to stop it within 14 days of start
- •of treatment
- •* Pregnant or lactating women
- •* Concomitant participation in another competing clinical study
- •* Absence of assurance of compliance with the protocol
- •* An organic brain syndrome or other significant psychiatric abnormality which
- •would comprise the ability to give informed consent, and preclude participation
- •in the full protocol and follow-up
研究者
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