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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01102231
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: A
Drug: Chemotherapy
Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)

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)

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

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 2 years ]

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01102231

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
Chartres, France
Cholet, France
Clermont-Ferrand, France
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
Longjumeau, France
Clinique des 4 Pavillons
Lormont, France
Hôpital Louis Pradel
Lyon, France
Hôpital Nord
Marseille, France
Centre Hospitalier
Montélimar, France
Nancy, France
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
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
Principal Investigator: Jean Trédaniel, MD, PhD IFCT, GH Paris Saint-Joseph
Principal Investigator: Françoise Mornex, MD, PhD IFCT, HCL Lyon-Sud

Additional Information:
Responsible Party: Intergroupe Francophone de Cancerologie Thoracique Identifier: NCT01102231     History of Changes
Other Study ID Numbers: IFCT-0803
First Posted: April 13, 2010    Key Record Dates
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
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors