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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

318 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-12-31

Brief Summary

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Description of clinical and anatomical features and long-term follow-up for patients with ALK rearrangement and treated by crizotinib

Detailed Description

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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.

Conditions

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Non-small Cell Lung Cancer Anaplastic Lymphoma Kinase Gene Mutation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intergroupe Francophone de Cancerologie Thoracique

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Angers - CHU

Angers, , France

Site Status

Angoulême - CH

Angoulême, , France

Site Status

Annecy - CH

Annecy, , France

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Avignon - Institut Sainte-Catherine

Avignon, , France

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CHU Besancon - Pneumologie

Besançon, , France

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Bordeaux - Clinique Saint Augustin

Bordeaux, , France

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Boulogne - Hôpital Ambroise Paré

Boulogne, , France

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Brest - Hôpital du Morvan

Brest, , France

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CH de Cannes

Cannes, , France

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CH Chambery

Chambéry, , France

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Clermont-Ferrand - CHU

Clermont-Ferrand, , France

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Clermont-Ferrand - Centre Jean Perrin

Clermont-Ferrand, , France

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Colmar - CH

Colmar, , France

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CH de Dax

Dax, , France

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Dijon - CHU

Dijon, , France

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Dole - Centre Hospitalier Louis Pasteur

Dole, , France

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Douai - CH

Douai, , France

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Fréjus - CHI Saint Raphaël

Fréjus, , France

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Grenoble - Institut Daniel Hollard

Grenoble, , France

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CHRU Grenoble

Grenoble, , France

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Centre Hospitalier - Pneumologie

Le Havre, , France

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Centre Hospitalier - Pneumologie

Le Mans, , France

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Libourne - CH

Libourne, , France

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Centre Oscar Lambret

Lille, , France

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Limoges - Hôpital du Cluzeau

Limoges, , France

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Longjumeau - CH

Longjumeau, , France

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Marseille - Hôpital Saint Joseph

Marseille, , France

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Marseille - CRLCC

Marseille, , France

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Polyclinique du Parc

Maubeuge, , France

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Mâcon - CH

Mâcon, , France

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Meaux - CH

Meaux, , France

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Meulan - CHI

Meulan-en-Yvelines, , France

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CH de Mulhouse

Mulhouse, , France

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Centre Antoine Lacassagne

Nice, , France

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Paris - Hôpital Cochin

Paris, , France

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Paris - Hôpital Saint Joseph

Paris, , France

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Paris - Hôpital Européen Georges Pompidou

Paris, , France

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Hopital Tenon - Pneumologie

Paris, , France

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Paris - Curie

Paris, , France

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Pau - CH

Pau, , France

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Lyon Sud

Pierre-Bénite, , France

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CHU

Poitiers, , France

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Reims - Institut Courlancy

Reims, , France

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Rennes - Clinique Saint Laurent

Rennes, , France

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Rodez - CH

Rodez, , France

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Rouen - CHU

Rouen, , France

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Saint Denis de la Réunion - CHD Guyon

Saint-Denis, , France

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Saint Herblain - Institut de Cancérologie de l'Ouest - René Gauducheau

Saint-Herblain, , France

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Saint-Julien-en-Genvois - CHI

Saint-Julien-en-Genevois, , France

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Saint Priest en Jarez - ICL

Saint-Priest-en-Jarez, , France

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Strasbourg - NHC

Strasbourg, , France

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Strasbourg - Centre Paul Strauss

Strasbourg, , France

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Suresnes - Hopital Foch

Suresnes, , France

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Centre Hospitalier Intercommunal

Toulon, , France

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Toulouse - Clinique Pasteur

Toulouse, , France

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Toulouse - CHU Larrey

Toulouse, , France

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Tours - CHU

Tours, , France

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Troyes - CH

Troyes, , France

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Vannes - Centre Hospitalier Bretagne Atlantique

Vannes, , France

Site Status

Vénissieux - Groupe Hospitalier Mutualiste les Portes du Sud

Vénissieux, , France

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CH de Villefranche - Pneumologie

Villefranche, , France

Site Status

Villejuif - Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

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.

Reference Type RESULT
PMID: 28423535 (View on PubMed)

Related Links

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http://www.ifct.fr

Official website

Other Identifiers

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IFCT-1302

Identifier Type: -

Identifier Source: org_study_id

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