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

This study has been completed.
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique Identifier:
First received: April 10, 2010
Last updated: March 1, 2017
Last verified: March 2017
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 Intervention Phase
Stage III Non-small Cell Lung Cancer Drug: Chemotherapy Drug: ERBITUX Radiation: Radiotherapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

Further study details as provided by Intergroupe Francophone de Cancerologie Thoracique:

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

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

Enrollment: 106
Actual Study Start Date: March 2010
Study Completion Date: December 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Additional Information:
Responsible Party: Intergroupe Francophone de Cancerologie Thoracique Identifier: NCT01102231     History of Changes
Other Study ID Numbers: IFCT-0803
Study First Received: April 10, 2010
Last Updated: March 1, 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 processed this record on August 16, 2017