Non-small Cell Lung Cancer Clinical Trial
— CLINALKOfficial title:
Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements
NCT number | NCT02727335 |
Other study ID # | IFCT-1302 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2014 |
Est. completion date | December 2015 |
Verified date | May 2023 |
Source | Intergroupe Francophone de Cancerologie Thoracique |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Description of clinical and anatomical features and long-term follow-up for patients with ALK rearrangement and treated by crizotinib
Status | Completed |
Enrollment | 318 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | 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 | Besancon | |
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 | Chambery | |
France | Clermont-Ferrand - Centre Jean Perrin | Clermont-Ferrand | |
France | Clermont-Ferrand - CHU | 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 | CHRU Grenoble | Grenoble | |
France | Grenoble - Institut Daniel Hollard | 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 | Mâcon - CH | Mâcon | |
France | Marseille - CRLCC | Marseille | |
France | Marseille - Hôpital Saint Joseph | Marseille | |
France | Polyclinique du Parc | Maubeuge | |
France | Meaux - CH | Meaux | |
France | Meulan - CHI | Meulan-en-Yvelines | |
France | CH de Mulhouse | Mulhouse | |
France | Centre Antoine Lacassagne | Nice | |
France | Hopital Tenon - Pneumologie | Paris | |
France | Paris - Curie | Paris | |
France | Paris - Hôpital Cochin | Paris | |
France | Paris - Hôpital Européen Georges Pompidou | Paris | |
France | Paris - Hôpital Saint Joseph | 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 Herblain - Institut de Cancérologie de l'Ouest - René Gauducheau | Saint Herblain | |
France | Saint Priest en Jarez - ICL | Saint Priest en Jarez | |
France | Saint Denis de la Réunion - CHD Guyon | Saint-Denis | |
France | Saint-Julien-en-Genvois - CHI | Saint-Julien-en-Genevois | |
France | Strasbourg - Centre Paul Strauss | Strasbourg | |
France | Strasbourg - NHC | Strasbourg | |
France | Suresnes - Hopital Foch | Suresnes | |
France | Centre Hospitalier Intercommunal | Toulon | |
France | Toulouse - CHU Larrey | Toulouse | |
France | Toulouse - Clinique Pasteur | 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 |
Lead Sponsor | Collaborator |
---|---|
Intergroupe Francophone de Cancerologie Thoracique |
France,
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-Sib — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | overall survival | overall survival post-progression on crizotinib | 5 years | |
Secondary | rare and severe complications of crizotinib therapy | Incidence of rare and severe complications of crizotinib therapy: hepatotoxicity, interstitial pneumonitis, diastolic heart failure | 5 years |
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