Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
This study is currently recruiting participants.
Verified February 2013 by Intergroupe Francophone de Cancerologie Thoracique
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: February 19, 2013
Last verified: February 2013
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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: | 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: | December 2013 |
| 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
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: | February 19, 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 June 17, 2013