NL-OMON33139撤回不适用
Etude de phase 1 évaluant le RAD001 en association avec la radiothérapie dans les cancers bronchiques non à petites cellules - RAD001-RT
ederlands Kanker Instituut0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 5
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
- •1) Unresectable non-small cell lung cancer, stage IIIA/B, or stage IV for which the primary tumor is symptomatic (cough, dyspnea, pain) without extra-thoracic lesions rapidly evolving
- •2) Measurable lesion, documented histologically, potentially accessible during fiberoptic bronchoscopy.
- •3) Age > 18 years, WHO 0-1,
- •4) Neutrophil count > 1500 /mm3, Hemoglobin > 9 g/dL, Platelet count > 100,000/mm3
- •5) Bilirubin < 1.5 mg/dL, Transaminases < 3 N, albumin >30 g / L, PT > 70%
- •6) Creatinine < 120 µM/L
- •7) Patient information and informed consent form signed.
- •8) No previous treatment for lung cancer (surgery, radiotherapy, chemotherapy).
排除标准
- •1) Patients previously treated with RAD001 (everolimus) or any other mTOR inhibitor
- •2) Stage IV for which the primary tumor is not symptomatic with extra-thoracic lesions rapidly evolving requiring systemic treatment
- •3) Previous radiotherapy,
- •4) Venous or arterial thrombosis, pulmonary embolism during the previous six months
- •5) Concomitant treatment with phenytoin, phenobarbital or any other antiepileptic agent, history of epilepsy
- •6) Concomitant treatment with medicinal products that inhibit, induce or are substrates for CYP3A4
研究者
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