Locally advanced non small cell lung cancer MedDRA version: 9.1 Level: LLT Classification code 10025053 Term: Lung cancer non-small cell stage IIIA
Conditions
Interventions
Trade Name: ERBITUX 5 mg/ml
Product Name: Cetuximab
Pharmaceutical Form: Solution for infusion
Sponsors
Institut de Cancérologie de la Loire
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Regarding the disease : - non-small cell lung cancer cytologically or histologically proven, favouring if possible the histological evidence (posterior study of the expression of the EGFR). - Stage III A-N2 unresectable or stage IIIB - Presence of at least one measurable target in one dimension (at least 10 mm in spiral tomodensitometry) - possibility to include all targets in one single irradiation field - The impossibility to carry out a study of the expression of the EGFR is not an exclusion criteria. Regarding the patient : - Age >=18 and = 1500/mm3, platelets >= 100 000/mm3 - Adequate kidney function : creatinine clearance >= 60ml/mm - Adequate liver function with total bilirubine = 40% in theory and diffusion capacity >= 50% in theory and PaO2 >= 60 mm Hg - Signed and dated informed consent document for the participation to the study before any test specific to the study - Signed and dated informed consent document for the use of biologicals samples Regarding the treatment : - Radiotherapy must be possible at a 66 Gy with dosimetry showing V20 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Regarding the disease : - Prior treatment for lung cancer except endoscopic disobstruction - operable cancer - small cell lung cancer, neuroendocrine cancer, bronchoalveolar cancer - metastatic lung cancer - Superior vena cava syndrome - Stage IIIB cancer with puncturable pleurisy (even if cytology is negative) - Stage IIIB cancer with neoplasia pericarditis - Impossibility to include all target in one single irradiation field Regarding the patient : - Prior thoracic irradiation - Other severe concomitant cardiac pathology, including congestive heart failure, unstable angina pectoris, arrythmia, or existence of a non balanced ischaemia myocardiopathy - pre-existing interstitial pulmonary pathology - Patient pre-treated by anti-EGFR and/or anti-VEGF therapeutics - Known allergy to murine proteins and known allergy to a treatment delivered in the study - non controlled infectious condition - HIV-positive patient - peripheric neuropathy grade >2 (NCI-CTCAE criteria) - neurological or psychiatric touble preventing from understanding the study - other organic defect likely to prevent inclusion in the trial - History or simultaneity of another cancer except basal-cell epithelioma or a treated cervix in-situ carcinoma, or any other cancer treated by surgery only for at least 5 years - pregnant or breast-feeding female patient. female patients of child-bearing age and all male patients must have an adequate contraception means during the trial and the following 3 months. - Impossible patient monitoring - patient deprived of freedom after an administrative or judiciary decision - Patients having taken part in a therapeutic trial of a new molecule (regardless of its interest : curative, prophylactic or diagnostic) in the previous 30 days, or taking part part in a running clinical trial. - Definitive contraindication to corticosteroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the feasibility in terms of toxicity of the association of cetuximab and concomitant radio-chemotherapy in each of both arms, in order to select the best arm of association.;Secondary Objective: in each of both treatment arms, to evaluate : - the compliance to the association of cetuximab and concomitant radio-chemotherapy - the global tolerance profile of treatments. A particular attention will be payed to the collection of lung toxicity until EVA2. In each of both treatment arms, to evaluate : - Objective response rate (full response and partial response) and the lasting of response to treatments - survival without progression and global survival - correlation between the expression of EGFR and toxicity, response and survival.;Primary end point(s): Primary end point: - Toxicity will be evaluated by the rate of patients having shown at least one non haematological event except nausea and vomit (TNHNV) grade >= 3 from randomisation to EVA2 (i.e. at the end of the concomitant treatment) according to the scale of the NCI-CTCAE (version 3.0) Secondary end points : - Compliance will be evaluated by : The intensity dose of the delievered concomitant chemotherapy compared to the theoritical intensity dose. Precise rules of doses diminution, temporary or final interruption of concomitant chemotherapy according to toxicities are defined in the protocol. - The intensity dose of delivered cetuximab during the concomitant radio-chemotherapy compared to the theoritical intensity dose. Precise rules of doses diminution, temporary or final interruption of concomitant cetuximab according to toxicities are defined in the protocol. Precise rules of temporary or final interruption of radiotherapy according to toxicities are defined in the protocol. - Global tolerance evaluated by the scale of the NCI-CTCAE (version 3.0) Tertiary end points: - Response : evaluated according to RECIST criteria - Survival without progression and global survival, calculate | — |
Countries
France
Outcome results
None listed