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Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
This study has been completed.
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 1, 2017
Last verified: March 2017
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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: | 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:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
Drug Information available for:
Cetuximab
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 ]
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
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) |
| Sexes Eligible for Study: | All |
| 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.
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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 1, 2017 |
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 August 16, 2017