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

Stage III Non-small Cell Lung Cancer Clinical Trial

Official title:

Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102231
• Other study ID #: IFCT-0803
• Status: Completed
• Phase: Phase 2
• Start date: March 2010
• Est. completion date: December 2015

Study information

• Verified date: January 2021
• Source: Intergroupe Francophone de Cancerologie Thoracique
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Stage III Non-small Cell Lung Cancer

Intervention

Drug:
• Chemotherapy
Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)
• 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)

Locations

Country	Name	City	State
France	Clinique de l'Europe	Amiens
France	Centre Hospitalier	Annemasse
France	CHU Besancon - Pneumologie	Besancon
France	Bordeaux - Polyclinique Nord	Bordeaux
France	Caen - Centre François Baclesse	Caen
France	Caen - CHU Côte de Nacre	Caen
France	CH	Chartres
France	CH	Cholet
France	CHU	Clermont-Ferrand
France	CH	Colmar
France	Clinique des Cèdres	Cornebarrieu
France	Dijon - CAC	Dijon
France	CHU Grenoble	Grenoble
France	Institut d'Oncologie Hartmann	Levallois
France	CHU (Hôpital Calmette) - Pneumologie	Lille
France	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	Hôpital du Val de Grâce	Paris
France	Hôpital Saint-Joseph	Paris
France	Perpignan - Centre Catalan d'Oncologie	Perpignan
France	HCL - Lyon Sud	Pierre Bénite
France	CHU	Poitiers
France	Centre Hospitalier	Rambouillet
France	Institut Jean Godinot	Reims
France	Reims - CHU	Reims
France	Centre Frederic Joliot	Rouen
France	Centre Etienne Dolet	Saint-Nazaire
France	Hôpitaux Universitaires - Nouvel Hôpital Civil	Strasbourg
France	Suresnes - Hopital Foch	Suresnes
France	Tours - CHU	Tours
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Intergroupe Francophone de Cancerologie Thoracique

Country where clinical trial is conducted

France, 

References & Publications (2)

Aupérin A, Le Péchoux 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-Control Rate	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	18-month Overall Survival Rate	Percentage of patient alive 18 months after registration	18 months
Secondary	Progression Free Survival	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)

External Links

•   IFCT official website