不可切除Ⅲ期非小细胞肺癌的治疗原则及问题PPT.pptVIP

/ Purpose This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40% (10 months → 14 months). Estimated Enrollment: 380 Study Start Date: May 2005 Estimated Study Completion Date: December 2012 Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure) concurrent chemoRT with docetaxel 20 mg/m2, carboplatin AUC=2 intravenously weekly for 6 wks with thoracic RT of at least 61 Gy in 33 fractions over 6.5 weeks 1: Experimental Tarceva 150mg Intervention: Drug: Erlotinib (tarceva) Drug: Erlotinib (tarceva) Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 5 years of therapy. 2: Placebo Comparator Matched Placebo Intervention: Drug: Placebo Drug: Placebo Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 5 years of therapy.  * Spigel DR, Hainsworth JD, Yardley DA, et al. Tracheoesophageal fistula formation in patients with lung cancer treated with chemoradiation and bevacizumab. J Clin Oncol 2010; 28:43–48. 入选患者：不可手术切除的III期NSCLC 非鳞癌 无心包及肋膜转移 年龄18 有可评价病灶 未接受治疗（生物，化疗，放疗） ECOG0-1分 The non–small-cell lung cancer trial included patients with unresectable stage III nonsquamous non–small-cell h