Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
NCT ID: NCT01102231
Last Updated: 2021-02-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
106 participants
INTERVENTIONAL
2010-03-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
Chemoradiotherapy
Chemotherapy
Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)
ERBITUX
The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes
Radiotherapy
66 Gy (2 Gy by fraction, 5 fractions by week)
Interventions
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Chemotherapy
Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)
ERBITUX
The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes
Radiotherapy
66 Gy (2 Gy by fraction, 5 fractions by week)
Eligibility Criteria
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Inclusion Criteria
* measurable disease (RECIST 1.1)
* ECOG performance status 0-1
* normal organ and marrow function
Exclusion Criteria
* 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
18 Years
70 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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Jean Trédaniel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
IFCT, GH Paris Saint-Joseph
Françoise Mornex, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
IFCT, HCL Lyon-Sud
Locations
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Clinique de l'Europe
Amiens, , France
Centre Hospitalier
Annemasse, , France
CHU Besancon - Pneumologie
Besançon, , France
Bordeaux - Polyclinique Nord
Bordeaux, , France
Caen - Centre François Baclesse
Caen, , France
Caen - CHU Côte de Nacre
Caen, , France
CH
Chartres, , France
CH
Cholet, , France
CHU
Clermont-Ferrand, , France
CH
Colmar, , France
Clinique des Cèdres
Cornebarrieu, , France
Dijon - CAC
Dijon, , France
CHU Grenoble
Grenoble, , France
Institut d'Oncologie Hartmann
Levallois-Perret, , France
CHU (Hôpital Calmette) - Pneumologie
Lille, , France
CH
Longjumeau, , France
Clinique des 4 Pavillons
Lormont, , France
Hôpital Louis Pradel
Lyon, , France
Hôpital Nord
Marseille, , France
Centre Hospitalier
Montélimar, , France
CHU
Nancy, , France
CH
Nevers, , France
Centre Hospitalier
Niort, , France
APHP - Hopital Tenon - Pneumologie
Paris, , France
Hôpital du Val de Grâce
Paris, , France
Hôpital Saint-Joseph
Paris, , France
Perpignan - Centre Catalan d'Oncologie
Perpignan, , France
HCL - Lyon Sud
Pierre-Bénite, , France
CHU
Poitiers, , France
Centre Hospitalier
Rambouillet, , France
Reims - CHU
Reims, , France
Institut Jean Godinot
Reims, , France
Centre Frederic Joliot
Rouen, , France
Centre Etienne Dolet
Saint-Nazaire, , France
Hôpitaux Universitaires - Nouvel Hôpital Civil
Strasbourg, , France
Suresnes - Hopital Foch
Suresnes, , France
Tours - CHU
Tours, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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Auperin A, Le Pechoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29.
Tredaniel J, Mornex F, Barillot I, Diaz O, Hennequin C, Le Pechoux C, Lavole A, Giraud P, Souquet PJ, Teixeira L, Vaylet F, Zalcman G, Baudrin L, Morin F, Milleron B. [A phase II study of cetuximab, pemetrexed, cisplatin, and concurrent radiotherapy in patients with locally advanced, unresectable, stage III, non squamous, non-small cell lung cancer (NSCLC)]. Rev Mal Respir. 2011 Jan;28(1):51-7. doi: 10.1016/j.rmr.2010.06.027. Epub 2011 Jan 11. French.
Related Links
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IFCT official website
Other Identifiers
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IFCT-0803
Identifier Type: -
Identifier Source: org_study_id
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