Feasibility of Cetuximab Associated With Concomitant Radio-Chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer

Institut de Cancérologie de la Loire

Status and phase: Completed; Phase 2

Conditions: Non-Small-Cell Lung Carcinoma

Treatments: Drug: cisplatin, vinorlebine, cetuximab; Drug: cisplatine, etoposide, cetuximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00985855

2008-005013-21 (EudraCT Number)

2008-03

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

Cisplatin, vinorelbine

Experimental group

Description:

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.

Treatment:

Drug: cisplatin, vinorlebine, cetuximab

Cisplatin, etoposide

Experimental group

Description:

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.

Treatment:

Drug: cisplatine, etoposide, cetuximab