Preoperative Twice Daily Chemoradiation in Addition to Chemotherapy Prior to Surgery in Stage III Non-Small Cell Lung Cancer (NSCLC)

Preoperative Twice Daily Chemoradiation in Addition to Chemotherapy Prior to Surgery in Stage III Non-Small Cell Lung Cancer (NSCLC)

Cisplatin/Etoposide Followed by Twice-Daily Chemoradiation (hfRT/CT) Versus Cisplatin/Etoposide Alone Before Surgery in Stage III Non-Small Cell Lung Cancer. A Phase III Trial of the German Lung Cancer Cooperative Group (GLCCG)

University Hospital Muenster, Lung Clinic Hemer, Kreiskrankenhaus Diekholzen, University Hospital, Saarland, FLT Berlin / Buch

Patients are randomized to (arm A) 3 cycles of cisplatin/etoposide, followed by hyperfractionated radiotherapy (hfRT)with concurrent carboplatin and vindesine then surgery and, if no or R1/2-resection, additional hfRT versus (arm B) 3 cycles of cisplatin/etoposide, followed by surgery and then RT. The primary endpoint was progression free survival (PFS). With 500 patients evaluable an improvement of median PFS from 10 to 14 months could be detected.

Patients are randomized to (arm A) 3 cycles of cisplatin 55 mg/m2 (d 1 + 4)/etoposide 100 mg/m2 (d 1-4), followed by hyperfractionated radiotherapy (hfRT; 45 Gy, 2x1.5 Gy/d) with concurrent carboplatin (100 mg/m2) and vindesine (3 mg) (d 1, 8, 15), then surgery and, if no or R1/2-resection, additional hfRT (24 Gy; 2x1.5 Gy/d) versus (arm B) 3 cycles of cisplatin 55 mg/m2 (d 1 + 4)/etoposide 100 mg/m2 (d 1-4),followed by surgery and then RT (1.8 Gy/d) with 54 Gy or, if no or R1/2-resection, 68.4 Gy. The primary endpoint was progression free survival (PFS). With 500 patients evaluable an improvement of median PFS from 10 to 14 months could be detected. (University of Münster was the lead sponsor; as the trial was implemented in clinicaltrials.gov by the principal investigator after he had moved to University of Heidelberg this account is announced above)

Inclusion Criteria: non-small cell lung cancer proven by histology stage IIIA / stage IIIB mediastinoscopy performance score ECOG 0,1 predicted postoperative FEV 1 > 1.0 l Exclusion Criteria: small cell lung cancer cardiac disability (NYHA III/IV) prior radio- or chemotherapy pregnancy other malignancy

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