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

Institut de Cancérologie de la Loire91 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small-Cell Lung Carcinoma

Interventions

cisplatin, vinorlebine, cetuximab

patient will receive 2 cycles of cisplatine 80 mg/m² at day 29 and day 50 more vinorelbine 15 mg/m² at day 29, day 36 and day 50 and 57 associated to cetuximab 400 mg/m² at day: 22,29, 36, 43, 50, 57, 64 and 71

cisplatine, etoposide, cetuximabDRUG

patient will receive 2 cycles of cisplatine 50 mg/m² at day 29, 36, 57, and 64 + étoposide 50mg/m² during day 29-33, day 57-61associated to cetuximab 400 mg/m² at day: 22,29, 36, 43, 50, 57, 64 and 71

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut de Cancerologie de la Loire

Saint-Priest-en-Jarez, France

Outcomes

Primary Outcomes

rate of patients presenting at least one toxicity grade≥3 (excepted hematological toxicity and nausea-vomiting)

Time frame: End of concomitant treatment (Day 71)

Data from ClinicalTrials.gov

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