NL-OMON56200招募中2 期
Intraperitoneal irinotecan with concomitant FOLFOX and bevacizumab for patients with unresectable colorectal peritoneal metastases - a phase II study - INTERACT-II
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 85
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
- •- Histologically confirmed colorectal cancer;
- •- Radiologically and clinically or pathologically confirmed unresectable
- •colorectal peritoneal metastases (e.g. PCI >20, extensive small bowel
- •involvement, unresectable disease due to anatomical location);
- •- WHO performance score of 0-1 with a life expectancy of >3 months;
- •- Aged 18 years or older;
- •- Written informed consent;
排除标准
- •- Presence of extensive systemic metastases that are deemed to be the dominant
- •factor determining prognosis in terms of life expectancy and performance status
- •[e.g. no imminent threat of impaired organ functioning due to the presence of
- •systemic metastases]);
- •- Prior cytoreductive surgery;
- •- Prior palliative systemic therapy for colorectal cancer;
- •- Prior neo-adjuvant/adjuvant systemic therapy for colorectal cancer within the
- •last 6 months;
- •- Homozygous UGT1A1*28 genotype;
- •- Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency;
- •- Microsatellite instable (MSI) primary tumor;
- •- Any contra-indication for the planned chemotherapy (e.g. active infection,
- •serious concomitant disease, severe allergy), as determined by the medical
- •oncologist;
- •- Inadequate organ functions, defined as an haemoglobin of <5 mmol/L, an
- •absolute neutrophil count of <1.5 x 109/L, platelet count of <100 x 109/L,
- •serum creatinine of >1.5 x ULN, creatinine clearance of <30 ml/min, Bilirubin >
- •2x ULN and liver transaminases of >5 x ULN;
研究者
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