Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements
NCT ID: NCT02727335
Last Updated: 2023-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
318 participants
OBSERVATIONAL
2014-05-31
2015-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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patients ALK + who received crizotinib
patients with ALK rearrangement who started treatment with crizotinib (250 mg twice a day) between the 18/11/2010 and the 31/12/2013 (will include patients from the ATU programs and patients treated after the marketing of crizotinib)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Patient with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
18 Years
ALL
No
Sponsors
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Intergroupe Francophone de Cancerologie Thoracique
OTHER
Responsible Party
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Principal Investigators
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Denis Moro-Sibilot
Role: PRINCIPAL_INVESTIGATOR
Intergroupe Francophone de Cancerologie Thoracique
Michael Duruisseaux
Role: PRINCIPAL_INVESTIGATOR
Intergroupe Francophone de Cancerologie Thoracique
Locations
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Agen - CH
Agen, , France
Angers - CHU
Angers, , France
Angoulême - CH
Angoulême, , France
Annecy - CH
Annecy, , France
Avignon - Institut Sainte-Catherine
Avignon, , France
CHU Besancon - Pneumologie
Besançon, , France
Bordeaux - Clinique Saint Augustin
Bordeaux, , France
Boulogne - Hôpital Ambroise Paré
Boulogne, , France
Brest - Hôpital du Morvan
Brest, , France
CH de Cannes
Cannes, , France
CH Chambery
Chambéry, , France
Clermont-Ferrand - CHU
Clermont-Ferrand, , France
Clermont-Ferrand - Centre Jean Perrin
Clermont-Ferrand, , France
Colmar - CH
Colmar, , France
CH de Dax
Dax, , France
Dijon - CHU
Dijon, , France
Dole - Centre Hospitalier Louis Pasteur
Dole, , France
Douai - CH
Douai, , France
Fréjus - CHI Saint Raphaël
Fréjus, , France
Grenoble - Institut Daniel Hollard
Grenoble, , France
CHRU Grenoble
Grenoble, , France
Centre Hospitalier - Pneumologie
Le Havre, , France
Centre Hospitalier - Pneumologie
Le Mans, , France
Libourne - CH
Libourne, , France
Centre Oscar Lambret
Lille, , France
Limoges - Hôpital du Cluzeau
Limoges, , France
Longjumeau - CH
Longjumeau, , France
Marseille - Hôpital Saint Joseph
Marseille, , France
Marseille - CRLCC
Marseille, , France
Polyclinique du Parc
Maubeuge, , France
Mâcon - CH
Mâcon, , France
Meaux - CH
Meaux, , France
Meulan - CHI
Meulan-en-Yvelines, , France
CH de Mulhouse
Mulhouse, , France
Centre Antoine Lacassagne
Nice, , France
Paris - Hôpital Cochin
Paris, , France
Paris - Hôpital Saint Joseph
Paris, , France
Paris - Hôpital Européen Georges Pompidou
Paris, , France
Hopital Tenon - Pneumologie
Paris, , France
Paris - Curie
Paris, , France
Pau - CH
Pau, , France
Lyon Sud
Pierre-Bénite, , 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 Herblain - Institut de Cancérologie de l'Ouest - René Gauducheau
Saint-Herblain, , France
Saint-Julien-en-Genvois - CHI
Saint-Julien-en-Genevois, , France
Saint Priest en Jarez - ICL
Saint-Priest-en-Jarez, , France
Strasbourg - NHC
Strasbourg, , France
Strasbourg - Centre Paul Strauss
Strasbourg, , France
Suresnes - Hopital Foch
Suresnes, , France
Centre Hospitalier Intercommunal
Toulon, , France
Toulouse - Clinique Pasteur
Toulouse, , France
Toulouse - CHU Larrey
Toulouse, , France
Tours - CHU
Tours, , France
Troyes - CH
Troyes, , France
Vannes - Centre Hospitalier Bretagne Atlantique
Vannes, , France
Vénissieux - Groupe Hospitalier Mutualiste les Portes du Sud
Vénissieux, , France
CH de Villefranche - Pneumologie
Villefranche, , France
Villejuif - Institut Gustave Roussy
Villejuif, , France
Countries
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References
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Duruisseaux M, Besse B, Cadranel J, Perol M, Mennecier B, Bigay-Game L, Descourt R, Dansin E, Audigier-Valette C, Moreau L, Hureaux J, Veillon R, Otto J, Madroszyk-Flandin A, Cortot A, Guichard F, Boudou-Rouquette P, Langlais A, Missy P, Morin F, Moro-Sibilot D. Overall survival with crizotinib and next-generation ALK inhibitors in ALK-positive non-small-cell lung cancer (IFCT-1302 CLINALK): a French nationwide cohort retrospective study. Oncotarget. 2017 Mar 28;8(13):21903-21917. doi: 10.18632/oncotarget.15746.
Related Links
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Official website
Other Identifiers
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IFCT-1302
Identifier Type: -
Identifier Source: org_study_id
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