Clinical trial NCT00985855: Feasibility of Cetuximab Associated With Concomitant Radio-Chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer
Official title: Feasibility of Cetuximab (ERBITUX®) Associated With Concomitant Radio-chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer: a Phase II, Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small-Cell Lung Carcinoma
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
First posted: 2009-09-29
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: rate of patients presenting at least one toxicity grade≥3 (excepted hematological toxicity and nausea-vomiting)
timeFrame: End of concomitant treatment (Day 71)
Secondary outcomes:
Other outcomes:
Locations:
city: St Priest en Jarez
country: France
facility: Institut de Cancerologie de la Loire
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Pierre FOURNEL, Dr
role: PRINCIPAL_INVESTIGATOR
References: