- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01102231
Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Amiens, France
- Clinique de l'Europe
-
Annemasse, France
- Centre Hospitalier
-
Besancon, France, 25000
- CHU Besancon - Pneumologie
-
Bordeaux, France, 33300
- Bordeaux - Polyclinique Nord
-
Caen, France, 14000
- Caen - Centre François Baclesse
-
Caen, France, 14000
- Caen - CHU Côte de Nacre
-
Chartres, France
- CH
-
Cholet, France
- CH
-
Clermont-Ferrand, France
- CHU
-
Colmar, France
- CH
-
Cornebarrieu, France
- Clinique des Cèdres
-
Dijon, France, 21000
- Dijon - CAC
-
Grenoble, France, 38000
- CHU Grenoble
-
Levallois, France
- Institut d'Oncologie Hartmann
-
Lille, France, 59000
- CHU (Hôpital Calmette) - Pneumologie
-
Longjumeau, France
- CH
-
Lormont, France
- Clinique des 4 Pavillons
-
Lyon, France
- Hôpital Louis Pradel
-
Marseille, France
- Hopital Nord
-
Montélimar, France
- Centre Hospitalier
-
Nancy, France
- CHU
-
Nevers, France
- CH
-
Niort, France
- Centre Hospitalier
-
Paris, France, 75020
- APHP - Hopital Tenon - Pneumologie
-
Paris, France
- Hôpital Saint-Joseph
-
Paris, France
- Hôpital du Val de Grâce
-
Perpignan, France, 66000
- Perpignan - Centre Catalan d'Oncologie
-
Pierre Bénite, France, 69495
- HCL - Lyon Sud
-
Poitiers, France
- CHU
-
Rambouillet, France
- Centre Hospitalier
-
Reims, France, 51092
- Reims - CHU
-
Reims, France
- Institut Jean Godinot
-
Rouen, France
- Centre Frédéric JOLIOT
-
Saint-Nazaire, France
- Centre Etienne DOLET
-
Strasbourg, France, 63000
- Hôpitaux Universitaires - Nouvel Hôpital Civil
-
Suresnes, France, 92151
- Suresnes - Hopital Foch
-
Tours, France, 37000
- Tours - CHU
-
Villejuif, France, 94800
- Institut Gustave Roussy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Chemoradiotherapy
|
Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)
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
66 Gy (2 Gy by fraction, 5 fractions by week)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease-Control Rate
Time Frame: 16 weeks after inclusion
|
percentage of patients with disease control (complete response + partial response + stable disease) according to RECIST 1.1 criteria Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for Progressive Disease (at least a 20% increase in the sum of diameters of target lesions). |
16 weeks after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
18-month Overall Survival Rate
Time Frame: 18 months
|
Percentage of patient alive 18 months after registration
|
18 months
|
Progression Free Survival
Time Frame: 52.3 months (median duration of follow-up)
|
Progression-free survival is defined as time between date of inclusion and progression or all-cause death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
52.3 months (median duration of follow-up)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jean Trédaniel, MD, PhD, IFCT, GH Paris Saint-Joseph
- Principal Investigator: Françoise Mornex, MD, PhD, IFCT, HCL Lyon-Sud
Publications and helpful links
General Publications
- Auperin A, Le Pechoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29.
- Tredaniel J, Mornex F, Barillot I, Diaz O, Hennequin C, Le Pechoux C, Lavole A, Giraud P, Souquet PJ, Teixeira L, Vaylet F, Zalcman G, Baudrin L, Morin F, Milleron B. [A phase II study of cetuximab, pemetrexed, cisplatin, and concurrent radiotherapy in patients with locally advanced, unresectable, stage III, non squamous, non-small cell lung cancer (NSCLC)]. Rev Mal Respir. 2011 Jan;28(1):51-7. doi: 10.1016/j.rmr.2010.06.027. Epub 2011 Jan 11. French.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IFCT-0803
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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