Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Radiochemotherapy is a standard for the treatment of unresectable stage III non-small cell lung cancer. The investigators goal is to study the efficacy and the toxicity for a promising association of new agents (cetuximab and pemetrexed) with concurrent radiotherapy.

Condition or disease	Intervention/treatment	Phase
Stage III Non-small Cell Lung Cancer	Drug: Chemotherapy; Drug: ERBITUX; Radiation: Radiotherapy	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	106 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
Actual Study Start Date :	March 2010
Actual Primary Completion Date :	January 2014
Actual Study Completion Date :	December 2015

Arms and Interventions

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Arm	Intervention/treatment
Experimental: A; Chemoradiotherapy	Drug: Chemotherapy; Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles) Drug: 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 Radiation: Radiotherapy; 66 Gy (2 Gy by fraction, 5 fractions by week)

Outcome Measures

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Primary Outcome Measures :

1. Disease-Control Rate [ Time Frame: 16 weeks after inclusion ]

Secondary Outcome Measures :

1. Overall Survival [ Time Frame: 2 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• non-squamous stage III non-small cell lung cancer
• measurable disease (RECIST 1.1)
• ECOG performance status 0-1
• normal organ and marrow function

Exclusion Criteria:

• prior chest radiation therapy
• 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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
Clinique de l'Europe
Amiens, France
Centre Hospitalier
Annemasse, France
CHU Besancon - Pneumologie
Besancon, France, 25000
Bordeaux - Polyclinique Nord
Bordeaux, France, 33300
Caen - Centre François Baclesse
Caen, France, 14000
Caen - CHU Côte de Nacre
Caen, France, 14000
CH
Chartres, France
CH
Cholet, France
CHU
Clermont-Ferrand, France
CH
Colmar, France
Clinique des Cèdres
Cornebarrieu, France
Dijon - CAC
Dijon, France, 21000
CHU Grenoble
Grenoble, France, 38000
Institut d'Oncologie Hartmann
Levallois, France
CHU (Hôpital Calmette) - Pneumologie
Lille, France, 59000
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, 75020
Hôpital du Val de Grâce
Paris, France
Hôpital Saint-Joseph
Paris, France
Perpignan - Centre Catalan d'Oncologie
Perpignan, France, 66000
HCL - Lyon Sud
Pierre Bénite, France, 69495
CHU
Poitiers, France
Centre Hospitalier
Rambouillet, France
Reims - CHU
Reims, France, 51092
Institut Jean Godinot
Reims, France
Centre Frederic Joliot
Rouen, France
Centre Etienne Dolet
Saint-Nazaire, France
Hôpitaux Universitaires - Nouvel Hôpital Civil
Strasbourg, France, 63000
Suresnes - Hopital Foch
Suresnes, France, 92151
Tours - CHU
Tours, France, 37000
Institut Gustave Roussy
Villejuif, France, 94800

Sponsors and Collaborators

Intergroupe Francophone de Cancerologie Thoracique

Investigators

Principal Investigator:	Jean Trédaniel, MD, PhD	IFCT, GH Paris Saint-Joseph
Principal Investigator:	Françoise Mornex, MD, PhD	IFCT, HCL Lyon-Sud

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

IFCT official website 

Publications:

Aupérin A, Le Péchoux 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. Review.

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.

Responsible Party:	Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:	NCT01102231 History of Changes
Other Study ID Numbers:	IFCT-0803
First Posted:	April 13, 2010
Last Update Posted:	March 3, 2017
Last Verified:	March 2017

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic	Bronchial Neoplasms; Pemetrexed; Cetuximab; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors