NL-OMON41603已完成不适用
Pre-operative Decitabine in Colon Cancer: a proof of principle study - DECO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
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 participate in the first part of the study, determination of methylation status on tumor biopsies, a subject must meet all of the following criteria:
- •1. Biopsy proven colon cancer or high suspicion of colon cancer.
- •2. Age >= 18yr.
- •3. Written informed consent.;In order to participate in the second part of the study - treatment with decitabine - a subject must meet all of the following criteria:
- •1. Patients with biopsy proven colon cancer who will undergo primary tumor resection.
- •2. Age >= 18yr.
- •3. ECOG/ WHO performance 0-2.
- •4. Adequate bone marrow function (ANC>1500/mm3, hemoglobin>9g/dL (which may be obtained by transfusions), platelets>100,000)
- •5. Adequate hepatic function (AST and ALT <2.5x upper limit of normal (ULN)).
- •6. Adequate renal function (Serum creatinine <=1.5 x ULN or calculated creatinine clearance of >50ml/min)
- •7. Women of child-bearing age must be willing to use adequate contraception and have negative serum or urine pregnancy test within 3 days prior to registration.
- •8. Written informed consent.;In order to participate part IIB of the study - obtaining tumor material - a subject must meet all of the following criteria:
- •1. Patients with biopsy proven colon cancer who will undergo primary tumor resection.
- •2. Age >= 18yr.
- •3. Karnofsky Performance Score 70.
- •4. Written informed consent.
排除标准
- •A potential subject for the first part of the study - determination of methylation status on tumor biopsies - who meets any of the following criteria will be excluded from participation in this study:
- •1. Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol.;A potential subject for the second part of the study - treatment with decitabine - who meets any of the following criteria will be excluded from participation in this study:
- •1. Known hypersensitivity to decitabine or its additives.
- •2. Surgery not planned according to time frame of the study,
- •3. Other systemic or local treatment of the primary tumor in the waiting time until surgery.
- •4. Administration of any experimental drug within 60 days prior to the first dose of decitabine.
- •5. Women of child-bearing age who are pregnant or lactating.
- •6. Sexual active males who have intercourse with women of child-bearing age and do not take adequate contraceptive measures.
- •7. Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol.;A potential subject for part IIB of the study - obtaining tumor material - who meets any of the following criteria will be excluded from participation in this study:
- •1. Surgery not planned according to time frame of the study
- •2. Other systemic or local treatment of the primary tumor in the waiting time until surgery.
- •3. Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol.
研究者
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