Non-Small Cell Lung Cancer Clinical Trial
Official title:
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)
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)
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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