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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00985855 |
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Date of registration:
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22/09/2009 |
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Primary sponsor: |
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Public title:
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Feasibility of Cetuximab Associated With Concomitant Radio-Chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer
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Scientific title:
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Feasibility of Cetuximab (ERBITUX®) Associated With Concomitant Radio-chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer: a Phase II, Randomised Study |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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62 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00985855 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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France
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Contacts
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Name:
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Pierre Fournel, MD |
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Address:
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Telephone:
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+33(0)477917036 |
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Email:
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pierre.fournel@icloire.fr |
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Affiliation:
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Name:
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Pierre Fournel, MD |
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Address:
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Telephone:
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+33(0)4917036 |
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Email:
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pierre.fournel@icloire.fr |
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Affiliation:
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Name:
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Pierre FOURNEL, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU SAINT-ETIENNE |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non-Small-Cell Lung Carcinoma
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Intervention(s)
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Drug: cisplatin, vinorlebine, cetuximab
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Drug: cisplatine, etoposide, cetuximab
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Primary Outcome(s)
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rate of patients presenting at least one toxicity grade=3 (excepted hematological toxicity and nausea-vomiting)
[Time Frame: End of concomitant treatment (Day 71)]
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Secondary ID(s)
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2008-005013-21
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2008-03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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