Clinical trial NCT01102231: Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
Official title: Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stage III Non-small Cell Lung Cancer
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
First posted: 2010-04-13
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Disease-Control Rate
timeFrame: 16 weeks after inclusion
Secondary outcomes:
measure: 18-month Overall Survival Rate
timeFrame: 18 months
measure: Progression Free Survival
timeFrame: 52.3 months (median duration of follow-up)
Other outcomes:
Locations:
city: Amiens
country: France
facility: Clinique de l'Europe
city: Annemasse
country: France
facility: Centre Hospitalier
city: Besancon
country: France
facility: CHU Besancon - Pneumologie
city: Bordeaux
country: France
facility: Bordeaux - Polyclinique Nord
city: Caen
country: France
facility: Caen - Centre François Baclesse
city: Caen
country: France
facility: Caen - CHU Côte de Nacre
city: Chartres
country: France
facility: CH
city: Cholet
country: France
facility: CH
city: Clermont-Ferrand
country: France
facility: CHU
city: Colmar
country: France
facility: CH
city: Cornebarrieu
country: France
facility: Clinique des Cèdres
city: Dijon
country: France
facility: Dijon - CAC
city: Grenoble
country: France
facility: CHU Grenoble
city: Levallois
country: France
facility: Institut d'Oncologie Hartmann
city: Lille
country: France
facility: CHU (Hôpital Calmette) - Pneumologie
city: Longjumeau
country: France
facility: CH
city: Lormont
country: France
facility: Clinique des 4 Pavillons
city: Lyon
country: France
facility: Hôpital Louis Pradel
city: Marseille
country: France
facility: Hôpital Nord
city: Montélimar
country: France
facility: Centre Hospitalier
city: Nancy
country: France
facility: CHU
city: Nevers
country: France
facility: CH
city: Niort
country: France
facility: Centre Hospitalier
city: Paris
country: France
facility: APHP - Hopital Tenon - Pneumologie
city: Paris
country: France
facility: Hôpital du Val de Grâce
city: Paris
country: France
facility: Hôpital Saint-Joseph
city: Perpignan
country: France
facility: Perpignan - Centre Catalan d'Oncologie
city: Pierre Bénite
country: France
facility: HCL - Lyon Sud
city: Poitiers
country: France
facility: CHU
city: Rambouillet
country: France
facility: Centre Hospitalier
city: Reims
country: France
facility: Reims - CHU
city: Reims
country: France
facility: Institut Jean Godinot
city: Rouen
country: France
facility: Centre Frederic Joliot
city: Saint-Nazaire
country: France
facility: Centre Etienne Dolet
city: Strasbourg
country: France
facility: Hôpitaux Universitaires - Nouvel Hôpital Civil
city: Suresnes
country: France
facility: Suresnes - Hopital Foch
city: Tours
country: France
facility: Tours - CHU
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: IFCT, GH Paris Saint-Joseph
name: Jean Trédaniel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IFCT, HCL Lyon-Sud
name: Françoise Mornex, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.