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

NCT ID: NCT00985855

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-08-31

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.

Conditions

Non-Small-Cell Lung Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cisplatin, vinorelbine

patients will receive induction chemotherapy (cisplatin, docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and vinorelbine associated with a weekly cetuximab infusion during the radiotherapy.

Group Type: EXPERIMENTAL

cisplatin, vinorlebine, cetuximab

Intervention Type: 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

Cisplatin, etoposide

patients will receive induction chemotherapy (cisplatin, docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and etoposide associated with a weekly cetuximab infusion during the radiotherapy.

Group Type: EXPERIMENTAL

cisplatine, etoposide, cetuximab

Intervention Type: 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

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

Intervention Type: DRUG

cisplatine, etoposide, cetuximab

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Cancérologie de la Loire

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre FOURNEL, Dr

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Institut de Cancerologie de la Loire

Saint-Priest-en-Jarez, , France

Countries

France

Other Identifiers

2008-005013-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2008-03

Identifier Type: -

Identifier Source: org_study_id