NL-OMON39053已完成不适用
Phase I Hybrid study: combined stereotactic radiotherapy and conventional fractionation in stage II and III non small cell lung cancer with peripheral tumors smaller than 5 cm - HYBRID
ederlands Kanker Instituut0 个研究点目标入组 15 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
- 已完成
- 发起方
- 入组人数
- 15
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
- •Cytological or histological proven NSCLC stage III or inoperable stage II, cT1-2a-3N1-3M0 with peripheral tumors < 5 cm (chest wall infiltration is no exclusion criteria if the tumor diameter is < 5 cm).
- •WHO-performance status <= 2 (Appendix B)
- •Patients that receive concurrent chemoradiotherapy, with the exception of adriamycin and gemcitabine (section 6.3)
- •FEV1 and DLCO > 40 % of the age-adjusted normal value
- •o Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) >=1.5 x 109/L, platelets >= 100 x 109/L, and hemoglobin >= 5.5 mmol/L.
- •o Hepatic: bilirubin <= 1.5 times the upper limit of normal (× ULN); alkaline phosphatase (AP), aspartate aminotransferase (ASAT), and alanine aminotransferase (ALAT) <= 3.0 × ULN.
- •o Renal: calculated creatinine clearance (CrCl) >= 45 ml/min based on the original weight based Cockcroft and Gault formula.
- •Before patient registration, written informed consent must be given according to GCP and national regulations
排除标准
- •Patients with central tumors < 2 cm of the proximal bronchial tree (Figure 2) or tumors immediately adjacent to mediastinal or pericardial pleura.
- •Patients that receive sequential chemoradiotherapy or radiotherapy only.
- •Patients with grade 3 dyspnea at baseline (according to CTCAE version 4.03)
- •Patients with Pancoast tumors
- •Pregnant women
研究者
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