Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements
- Conditions
- Anaplastic Lymphoma Kinase Gene MutationNon-small Cell Lung Cancer
- Registration Number
- NCT02727335
- Lead Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Brief Summary
Description of clinical and anatomical features and long-term follow-up for patients with ALK rearrangement and treated by crizotinib
- Detailed Description
Several French studies on crizotinib have been conducted in recent years. These are not only patients treated in the PROFILE 1005 and 1007 clinical studies but also patients who have been treated with crizotinib in the named patient ATU followed by the cohort ATU (Expended Access Cohort). Under the ATU program and according to ATU regulations, a limited set of data is collected and furthermore the follow up is stopped as soon as the ATU program closes. Thus it is not possible to have access to long term data and post progression data. Our project is to collect data from the patients from the ATU program (named patient and cohort) and if possible patients treated after the marketing of crizotinib, before, during and after crizotinib therapy. Centers selected for this observational study will be those of the IFCT network that took part in the ATU program.
This will allow an accurate analysis of crizotinib therapy under "real life" conditions. It should be emphasized that this information is generally neither available from clinical trials nor from ATU programs.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 318
- Patient must have locally advanced or metastatic NSCLC (Stage IIIb or Stage IV by AJCC 7th.) with positive ALK determined by IHC and/or FISH.
- Patient who received crizotinib on an expanded access basis (compassionate use) (ATU) due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable
- Patient who received marketed crizotinib as a result of the standard care of metastatic NSCLC (Stage IIIb or Stage IV by AJCC 7th.) with positive ALK will also be eligible.
- Patient was able to swallow capsules and had no surgical or anatomical condition that precluded the patient from swallowing and absorbing oral medications on an ongoing basis.
- Patient has taken at least 1 week of treatment
- Patient included in a crizotinib clinical trial
- Patient with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival 5 years overall survival post-progression on crizotinib
- Secondary Outcome Measures
Name Time Method rare and severe complications of crizotinib therapy 5 years Incidence of rare and severe complications of crizotinib therapy: hepatotoxicity, interstitial pneumonitis, diastolic heart failure
Trial Locations
- Locations (62)
Tours - CHU
🇫🇷Tours, France
Agen - CH
🇫🇷Agen, France
Angers - CHU
🇫🇷Angers, France
Colmar - CH
🇫🇷Colmar, France
Avignon - Institut Sainte-Catherine
🇫🇷Avignon, France
Meulan - CHI
🇫🇷Meulan-en-Yvelines, France
CH Chambery
🇫🇷Chambery, France
Clermont-Ferrand - CHU
🇫🇷Clermont-Ferrand, France
Clermont-Ferrand - Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Grenoble - Institut Daniel Hollard
🇫🇷Grenoble, France
Meaux - CH
🇫🇷Meaux, France
Paris - Hôpital Saint Joseph
🇫🇷Paris, France
Centre Hospitalier - Pneumologie
🇫🇷Le Mans, France
Limoges - Hôpital du Cluzeau
🇫🇷Limoges, France
Hopital Tenon - Pneumologie
🇫🇷Paris, France
Saint Herblain - Institut de Cancérologie de l'Ouest - René Gauducheau
🇫🇷Saint Herblain, France
Angoulême - CH
🇫🇷Angoulême, France
CHU Besancon - Pneumologie
🇫🇷Besancon, France
Bordeaux - Clinique Saint Augustin
🇫🇷Bordeaux, France
Douai - CH
🇫🇷Douai, France
Annecy - CH
🇫🇷Annecy, France
Boulogne - Hôpital Ambroise Paré
🇫🇷Boulogne, France
CH de Cannes
🇫🇷Cannes, France
Brest - Hôpital du Morvan
🇫🇷Brest, France
Dijon - CHU
🇫🇷Dijon, France
CH de Dax
🇫🇷Dax, France
Dole - Centre Hospitalier Louis Pasteur
🇫🇷Dole, France
Fréjus - CHI Saint Raphaël
🇫🇷Fréjus, France
CHRU Grenoble
🇫🇷Grenoble, France
Libourne - CH
🇫🇷Libourne, France
Centre Oscar Lambret
🇫🇷Lille, France
Longjumeau - CH
🇫🇷Longjumeau, France
Marseille - Hôpital Saint Joseph
🇫🇷Marseille, France
Marseille - CRLCC
🇫🇷Marseille, France
Polyclinique du Parc
🇫🇷Maubeuge, France
CH de Mulhouse
🇫🇷Mulhouse, France
Paris - Hôpital Cochin
🇫🇷Paris, France
Mâcon - CH
🇫🇷Mâcon, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Toulouse - CHU Larrey
🇫🇷Toulouse, France
Paris - Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Lyon Sud
🇫🇷Pierre Bénite, France
Paris - Curie
🇫🇷Paris, France
Pau - CH
🇫🇷Pau, France
CHU
🇫🇷Poitiers, France
Reims - Institut Courlancy
🇫🇷Reims, France
Rennes - Clinique Saint Laurent
🇫🇷Rennes, France
Rodez - CH
🇫🇷Rodez, France
Rouen - CHU
🇫🇷Rouen, France
Saint Denis de la Réunion - CHD Guyon
🇫🇷Saint-Denis, France
Saint Priest en Jarez - ICL
🇫🇷Saint Priest en Jarez, France
Centre Hospitalier Intercommunal
🇫🇷Toulon, France
Saint-Julien-en-Genvois - CHI
🇫🇷Saint-Julien-en-Genevois, France
Suresnes - Hopital Foch
🇫🇷Suresnes, France
Strasbourg - NHC
🇫🇷Strasbourg, France
Strasbourg - Centre Paul Strauss
🇫🇷Strasbourg, France
Toulouse - Clinique Pasteur
🇫🇷Toulouse, France
Troyes - CH
🇫🇷Troyes, France
Vannes - Centre Hospitalier Bretagne Atlantique
🇫🇷Vannes, France
Villejuif - Institut Gustave Roussy
🇫🇷Villejuif, France
CH de Villefranche - Pneumologie
🇫🇷Villefranche, France
Vénissieux - Groupe Hospitalier Mutualiste les Portes du Sud
🇫🇷Vénissieux, France