Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
This study is ongoing, but not recruiting participants.
Sponsor:
Intergroupe Francophone de Cancerologie Thoracique
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT01102231
First received: April 10, 2010
Last updated: March 9, 2016
Last verified: March 2016
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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: | 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:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
U.S. FDA Resources
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 ]
| Enrollment: | 106 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | December 2016 |
| 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 (Adult, Senior) |
| 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
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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
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: | March 9, 2016 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic |
Bronchial Neoplasms Pemetrexed Cetuximab Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on September 23, 2016