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Abstract
Purpose: the aim of this prospective randomized study was to evaluate the effect of accelerated hyperfractionated radiotherapy weekend less (CHARTWEL) when combined with chemotherapy (cisplatin and vinorelbine) versus conventional radiotherapy combined with the same drugs in the treatment of locally advanced (stage IIIA and IIIB) NSCLC in terms of response rate, progression free survival, 1 and 2 years survival rate, median overall survival as well as the morbidity caused by these lines of therapy.
Material and methods: Forty eligible patients were randomized to be treated in two arms (arm A and arm B) during the period from April 2003 to April 2005;inclusive, in the NEMROCK. Arm A included 20 eligible patients who received conventional radiotherapy 6120 cGy to the primary tumor and mediastinal lymph nodes,180 cGy/ fraction once per day, 5 days per week in 5.5 weeks combined with cisplatin 60 mg/m2 D1 and vinorelbine 16 mg/m2 D1 and D8 to be repeated every 21 days during the course of irradiation. Arm B included 20 eligible patients who
received CHARTWEL protocol 5400 cGy to the primary and mediastinal lymph nodes, 150 cGy / fraction 3 times/ day over 16 days combined with the same drugs and same doses given in Arm A. In both arms assessment of response was done by CT-chest 3 weeks from end of concomitant chemoradiotherapy. Patients who responded or even showed stable
disease completed on chemotherapy to a total of six cycles but with cisplatin 80 mg/m2 D1 and vinorelbine 25 mg/m2 D1 and D8 every 3 weeks. Follow-up CT-chest is done every 3 months during the first and second years of follow-up.