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

Primary Purpose

Non-Small-Cell Lung Carcinoma

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

cisplatin, vinorlebine, cetuximab

cisplatine, etoposide, cetuximab

About this trial

This is an interventional treatment trial for Non-Small-Cell Lung Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institut de Cancerologie de la Loire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cisplatin, vinorelbine

Cisplatin, etoposide

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

rate of patients presenting at least one toxicity grade≥3 (excepted hematological toxicity and nausea-vomiting)

Secondary Outcome Measures

Full Information

NCT ID

NCT00985855

First Posted

September 22, 2009

Last Updated

September 13, 2017

Sponsor

Institut de Cancérologie de la Loire

1. Study Identification

Unique Protocol Identification Number

NCT00985855

Brief Title

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

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut de Cancérologie de la Loire

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small-Cell Lung Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

91 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cisplatin, vinorelbine

Arm Type

Experimental

Arm Description

Arm Title

Cisplatin, etoposide

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

cisplatin, vinorlebine, cetuximab

Intervention Description

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

Intervention Name(s)

cisplatine, etoposide, cetuximab

Intervention Description

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 Outcome Measure Information:

Title

rate of patients presenting at least one toxicity grade≥3 (excepted hematological toxicity and nausea-vomiting)

Time Frame

End of concomitant treatment (Day 71)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierre FOURNEL, Dr

Organizational Affiliation

CHU SAINT-ETIENNE

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut de Cancerologie de la Loire

City

St Priest en Jarez

ZIP/Postal Code

42271

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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