The purpose of this study is to determine the 1-year rate of locoregional disease control in the experimental arm, using a control arm to avoid selection bias.
* To determine the 1-year rate of locoregional disease control in the experimental arm, using a control arm to avoid selection bias. * To determine the 2 and 3 year rate of locoregional disease control. * To evaluate the safety and toxicity of the combination of cetuximab and concomitant-boost accelerated radiotherapy followed by 12 weeks of complementary treatment with cetuximab. Both acute and chronic toxicity will be assessed. * To determine specific disease-free survival, event-free survival, disease-specific survival and overall survival * To determine acute and late toxicity * To determine EGFR, p53, Ki67, and evaluate its value as a prognostic factor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Hospital Germans Tries i Pujol
Badalona, Barcelona, Spain
RECRUITING1-year rate of Locoregional Disease Control in the experimental arm, deffined as complete and persistent disappearance of disease in the primary tumour and regional lymph nodes.
Toxicity and safety of treatment will be evaluated using the Common Toxicity Criteria (CTC) of the NCI, version 3.0.; and late toxicity from radiotherapy, using RTOG/EORTC Late Radiation Morbidity Scoring Scheme.
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H. del Mar / H. de la Esperanza
Barcelona, Barcelona, Spain
H. de la Santa Creu I Sant Pau
Barcelona, Barcelona, Spain
RECRUITINGInstitut Catala Oncologia: Hospital Duran y Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
RECRUITINGCentro Oncológico Regional de Galicia
A Coruña, Coruña, Spain
RECRUITINGH. Josep Trueta (ICO)
Girona, Girona, Spain
RECRUITINGH. G. Doctor Negrín
Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain
RECRUITINGClinica Ruber Internacional
Madrid, Madrid, Spain
RECRUITINGH. Ramón y Cajal
Madrid, Madrid, Spain
RECRUITINGFundación Jiménez Díaz
Madrid, Madrid, Spain
RECRUITING...and 8 more locations