Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
- Conditions
- Stage III Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT01102231
- Lead Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Brief Summary
Radiochemotherapy is a standard for the treatment of unresectable stage III non-small cell lung cancer. The investigators goal is to study the efficacy and the toxicity for a promising association of new agents (cetuximab and pemetrexed) with concurrent radiotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- non-squamous stage III non-small cell lung cancer
- measurable disease (RECIST 1.1)
- ECOG performance status 0-1
- normal organ and marrow function
- prior chest radiation therapy
- history of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last five years.
- Prior therapy with known specific inhibitors of the EGFR.
- history of severe allergic reaction to prior therapy with monoclonal antibodies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Chemotherapy Chemoradiotherapy A ERBITUX Chemoradiotherapy A Radiotherapy Chemoradiotherapy
- Primary Outcome Measures
Name Time Method Disease-Control Rate 16 weeks after inclusion percentage of patients with disease control (complete response + partial response + stable disease) according to RECIST 1.1 criteria Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for Progressive Disease (at least a 20% increase in the sum of diameters of target lesions).
- Secondary Outcome Measures
Name Time Method 18-month Overall Survival Rate 18 months Percentage of patient alive 18 months after registration
Progression Free Survival 52.3 months (median duration of follow-up) Progression-free survival is defined as time between date of inclusion and progression or all-cause death.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Trial Locations
- Locations (29)
Caen - Centre François Baclesse
🇫🇷Caen, France
Institut d'Oncologie Hartmann
🇫🇷Levallois, France
Perpignan - Centre Catalan d'Oncologie
🇫🇷Perpignan, France
Centre Etienne Dolet
🇫🇷Saint-Nazaire, France
CHU Besancon - Pneumologie
🇫🇷Besancon, France
Centre Hospitalier
🇫🇷Rambouillet, France
CH
🇫🇷Nevers, France
CHU Grenoble
🇫🇷Grenoble, France
Institut Jean Godinot
🇫🇷Reims, France
Hôpital Nord
🇫🇷Marseille, France
CHU
🇫🇷Poitiers, France
APHP - Hopital Tenon - Pneumologie
🇫🇷Paris, France
Hôpital du Val de Grâce
🇫🇷Paris, France
Reims - CHU
🇫🇷Reims, France
Centre Frederic Joliot
🇫🇷Rouen, France
Hôpital Louis Pradel
🇫🇷Lyon, France
Dijon - CAC
🇫🇷Dijon, France
CHU (Hôpital Calmette) - Pneumologie
🇫🇷Lille, France
Hôpitaux Universitaires - Nouvel Hôpital Civil
🇫🇷Strasbourg, France
Tours - CHU
🇫🇷Tours, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Clinique de l'Europe
🇫🇷Amiens, France
Clinique des Cèdres
🇫🇷Cornebarrieu, France
Caen - CHU Côte de Nacre
🇫🇷Caen, France
Bordeaux - Polyclinique Nord
🇫🇷Bordeaux, France
Clinique des 4 Pavillons
🇫🇷Lormont, France
Hôpital Saint-Joseph
🇫🇷Paris, France
HCL - Lyon Sud
🇫🇷Pierre Bénite, France
Suresnes - Hopital Foch
🇫🇷Suresnes, France