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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Intergroupe Francophone de Cancerologie Thoracique
Sponsor:
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT01102231
First received: April 10, 2010
Last updated: July 18, 2013
Last verified: August 2013
  Purpose

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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01102231

Contacts
Contact: Franck Morin +33.1.56.81.10.45 contact@ifct.fr

Locations
France
Clinique de l'Europe Recruiting
Amiens, France
Contact: Olivier CARRE, MD         
Centre Hospitalier Recruiting
Annemasse, France
Contact: Patrick CHATELLAIN         
CHU Besancon - Pneumologie Recruiting
Besancon, France, 25000
Contact: Virginie Westeel, Pr       contact@ifct.fr   
Bordeaux - Polyclinique Nord Recruiting
Bordeaux, France, 33300
Contact: François GUICHARD, Dr         
Caen - Centre François Baclesse Recruiting
Caen, France, 14000
Contact: Delphine LEROUGE, MD         
Caen - CHU Côte de Nacre Recruiting
Caen, France, 14000
Contact: Gerard ZALCMAN, Pr         
CH Recruiting
Chartres, France
Contact: Olivier RAFFY         
CH Recruiting
Cholet, France
Contact: Philippe MASSON         
CHU Recruiting
Clermont-Ferrand, France
Contact: Henri JANICOT         
CH Recruiting
Colmar, France
Contact: Lionel MOREAU         
Clinique des Cèdres Recruiting
Cornebarrieu, France
Contact: Pascal DEBOVE, MD         
Dijon - CAC Recruiting
Dijon, France, 21000
Contact: Karine Peignaux, Dr         
CHU Grenoble Recruiting
Grenoble, France, 38000
Contact: Julie VILLA, MD         
Institut d'Oncologie Hartmann Recruiting
Levallois, France
Contact: Jean-Michel VANNETZEL         
CHU (Hôpital Calmette) - Pneumologie Recruiting
Lille, France, 59000
Contact: Arnaud Scherpereel, Dr         
CH Recruiting
Longjumeau, France
Contact: Gérard OLIVIERO         
Clinique des 4 Pavillons Recruiting
Lormont, France
Contact: Pierre GUICHARD, MD         
Hôpital Louis Pradel Recruiting
Lyon, France
Contact: Nicolas GIRARD, MD         
Hôpital Nord Recruiting
Marseille, France
Contact: Fabrice BARLESI, MD, PhD         
Centre Hospitalier Recruiting
Montélimar, France
Contact: Bernard DUVERT, MD         
CHU Recruiting
Nancy, France
Contact: Yves MARTINET, MD, PhD         
CH Recruiting
Nevers, France
Contact: Dominique HERMAN         
Centre Hospitalier Recruiting
Niort, France
Contact: Paul GESTA, MD         
Hôpital du Val de Grâce Recruiting
Paris, France
Contact: Sylvestre LE MOULEC, MD         
APHP - Hopital Tenon - Pneumologie Recruiting
Paris, France, 75020
Contact: Armelle LAVOLE, Dr         
Hôpital Saint-Joseph Recruiting
Paris, France
Contact: Jean TREDANIEL, MD, PhD         
Perpignan - Centre Catalan d'Oncologie Recruiting
Perpignan, France, 66000
Contact: Jean DOMAS, Dr         
HCL - Lyon Sud Recruiting
Pierre Bénite, France, 69495
Contact: Françoise MORNEX, MD, PhD         
CHU Recruiting
Poitiers, France
Contact: Corinne LAMOUR, MD         
Centre Hospitalier Not yet recruiting
Rambouillet, France
Contact: Hélène LAIZE, MD         
Institut Jean Godinot Recruiting
Reims, France
Contact: Alain PREVOST, MD         
Reims - CHU Recruiting
Reims, France, 51092
Contact: Lidia PETIT, Dr         
Centre Frederic Joliot Recruiting
Rouen, France
Contact: Aude TOULEMONDE         
Centre Etienne Dolet Recruiting
Saint-Nazaire, France
Contact: Catherine LIGEZA POISSON         
Hôpitaux Universitaires - Nouvel Hôpital Civil Recruiting
Strasbourg, France, 63000
Contact: Elisabeth Quoix, MD, PhD         
Principal Investigator: Elisabeth Quoix, Pr         
Suresnes - Hopital Foch Recruiting
Suresnes, France, 92151
Contact: Sylvie Friard, Dr         
Tours - CHU Recruiting
Tours, France, 37000
Contact: Eric Pichon, MD         
Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Contact: Cécile Le Péchoux, MD         
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

Additional Information:
Publications:
Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT01102231     History of Changes
Other Study ID Numbers: IFCT-0803
Study First Received: April 10, 2010
Last Updated: July 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014