Feasibility of Cetuximab Associated With Concomitant Radio-Chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer
Phase 2
Completed
- Conditions
- Non-Small-Cell Lung Carcinoma
- Interventions
- Drug: cisplatine, etoposide, cetuximabDrug: cisplatin, vinorlebine, cetuximab
- Registration Number
- NCT00985855
- Lead Sponsor
- Institut de Cancérologie de la Loire
- 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-chemotherapy including 2 cycles of cisplatin and vinorelbine associated with a weekly cetuximab infusion during the radiotherapy.
* Arm B: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and etoposide associated with a weekly cetuximab infusion during the radiotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cisplatin, etoposide cisplatine, etoposide, cetuximab patients will receive induction chemotherapy (cisplatin, docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and etoposide associated with a weekly cetuximab infusion during the radiotherapy. Cisplatin, vinorelbine cisplatin, vinorlebine, cetuximab patients will receive induction chemotherapy (cisplatin, docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and vinorelbine associated with a weekly cetuximab infusion during the radiotherapy.
- Primary Outcome Measures
Name Time Method rate of patients presenting at least one toxicity grade≥3 (excepted hematological toxicity and nausea-vomiting) End of concomitant treatment (Day 71)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institut de Cancerologie de la Loire
🇫🇷St Priest en Jarez, France