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

KI-AV0 个研究点开始时间: 2012年6月4日最近更新: 2013年6月17日

适应症

试验速览

暂无简介。

•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
•oAdequate 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.
•oHepatic: bilirubin = 1.5 times the upper limit of normal (× ULN); alkaline phosphatase (AP), aspartate aminotransferase (ASAT), and alanine aminotransferase (ALAT) = 3.0 × ULN.
•oRenal: 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 5
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•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

发起方

KI-AV