67
Participants
Start Date
November 30, 2006
Primary Completion Date
June 30, 2009
Study Completion Date
January 31, 2014
Lapatinib oral tablets
Lapatinib is administered orally once daily.
radiotherapy
Radiotherapy is given either as conventional fractionation using Two-dimensional (2D) or conformal techniques, or as Intensity Modulated Radiation Therapy (IMRT). Radiation therapy will be standardised throughout the study. Radiation therapy is given only once daily, with a dose/fraction not exceeding 2.5Gy, to a total dose of 65 Gy (IMRT) or 70 Gy (2D or 3D RT) to the gross site of disease .
cisplatin chemotherapy
Cisplatin is administered intravenously at a dose of 100mg/m2 on days 1, 22 and 43 of radiotherapy (approximately Study Days 8, 29 and 50).
GSK Investigational Site, Budapest
GSK Investigational Site, Győr
GSK Investigational Site, Madrid
GSK Investigational Site, Charlotte
GSK Investigational Site, Vandœuvre-lès-Nancy
GSK Investigational Site, Minneapolis
GSK Investigational Site, Lille
GSK Investigational Site, Lens
GSK Investigational Site, Kansas City
GSK Investigational Site, Lyon
GSK Investigational Site, Paris
GSK Investigational Site, Ahemdabad
GSK Investigational Site, Mumbai
GSK Investigational Site, Thiruvananthapuram
GSK Investigational Site, Hamilton
GSK Investigational Site, Québec
GSK Investigational Site, Sherbrooke
GSK Investigational Site, Amsterdam
GSK Investigational Site, Leiden
GSK Investigational Site, Lima
GSK Investigational Site, Lima
GSK Investigational Site, Barcelona
GSK Investigational Site, Cambridge
GSK Investigational Site, Northwood
GSK Investigational Site, Coventry
GSK Investigational Site, Leeds
GSK Investigational Site, London
GSK Investigational Site, London
GSK Investigational Site, Newcastle upon Tyne
GSK Investigational Site, Sheffield
Lead Sponsor
GlaxoSmithKline
INDUSTRY