Feasibility of Cetuximab (ERBITUX®) Associated With Concomitant Radio-chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer: a Phase II, Randomised Study
Inclusion Criteria:
- Non-Small-Cell Lung cancer cytologically or histologically proved
- Stage III AN2 inoperable or non resectable
- presence of at least one one dimension measurable target (at least 10 mm with spiral
tomodensitometry)
- Possibility to include all targets in one irradiation field
- Age of 18 to 70
- Patients non previously treated
- Performance Status 0 or 1
- Loss of weight ≤10% in the 3 last months
- Neutrophil ≥ 1500/mm3 and platelets ≥ 100000/mm3
- Creatinine clearance ≥ 60 ml/min
- total bilirubin ≤ 1,5N and ASAT ALAT ≤ 2,5N
- Respiratory function normal: VEMS ≥ 40% theorical, DLCO/VA ≥ 50% theorical and PaO2 ≥
60 mmHg
- Signed inform consent form
- Compliance to radiotherapy 66 Gy with dosimetry V20 ≤ 35% and pulmonary mean dose≤20
Gy
Exclusion Criteria:
- Pretreated bronchial carcinoma, excepted endoscopic deobstruction
- operable bronchial carcinoma
- small cell lung cancer, composite cancer, neuroendocrine cancer, broncho alveolar
cancer
- superior vena cava syndroms
- puncturable pleural effusion
- metastatic lung cancer
- Stage IIIb cancer with neoplastic pericarditis
- Previous thoracic irradiation
- severe cardiac disease in the 12 months before inclusion
- interstitial lung disease
- anti-EGFR and anti-VEGF treatments
- hypersensitivity to murine proteins and allergies to protocol drugs
- uncontrolled infectious state
- HIV patient
- corticoid definitive contraindication
- péripheric neuropathy grade≥2
- neurologic, psychiatric and organic disorder
- past or concomitant cancer excepted treated skin baso-cellular cancer or in situ
cervical cancer, or any cancer only surgically treated for 5 years
- breastfeeding woman