NL-OMON51789招募中不适用
Concomitant intraperitoneal and systemic chemotherapy in patients with extensive peritoneal carcinomatosis of gastric origin - INTERACT stomach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
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 with a histologically confirmed diagnosis of HER2-negative gastric
- •A histologically confirmed diagnosis of macroscopic peritoneal carcinomatosis
- •(PCI >=1).
- •Age >= 18 years old.
- •Written informed consent according to the ICH-GCP and national/local
- •regulations.
- •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 or 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
- •Medical or psychological impediment to probable compliance with the protocol.
- •Serious concomitant disease or active infections.
- •Distant metastasis other than peritoneal metastasis or metastatic lymph
- •No sufficient oral food intake.
- •Polyneuropathy grade 2 or worse according to CTCAE version 5.0.
- •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 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 a 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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