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

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.

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Key information

Conditions

Non-Small-Cell Lung Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut de Cancerologie de la Loire

Saint-Priest-en-Jarez, 42271, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cisplatin, vinorlebine, cetuximab

Drug

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, cetuximab

Drug

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

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)

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de la Loire

Other

Registry information

Official study 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

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Sep 29, 2009
Registry last updated: Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed