Status:
COMPLETED
Feasibility of Cetuximab Associated With Concomitant Radio-Chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer
Lead Sponsor:
Institut de Cancérologie de la Loire
Conditions:
Non-Small-Cell Lung Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Phase II, randomised, controlled, non comparative study with 2 parallel groups: * Arm A: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemoth...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00985855
Start Date
September 1 2009
End Date
August 1 2011
Last Update
September 14 2017
Active Locations (1)
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1
Institut de Cancerologie de la Loire
Saint-Priest-en-Jarez, France, 42271