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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT01102231
First received: April 10, 2010
Last updated: August 11, 2014
Last verified: August 2014
  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: January 2019
Primary Completion Date: January 2014 (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

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

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: August 11, 2014
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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014