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

Intergroupe Francophone de Cancerologie Thoracique106 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

106

Conditions

Stage III Non-small Cell Lung Cancer

Interventions

ChemotherapyDRUG

Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)

ERBITUXDRUG

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

RadiotherapyRADIATION

66 Gy (2 Gy by fraction, 5 fractions by week)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (38)

Outcomes

Primary Outcomes

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).

Time frame: 16 weeks after inclusion

Secondary Outcomes

18-month Overall Survival Rate

Percentage of patient alive 18 months after registration

Time frame: 18 months

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.

Time frame: 52.3 months (median duration of follow-up)

Data from ClinicalTrials.gov

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Clinique de l'Europe

Amiens, France

Centre Hospitalier

Annemasse, France

CHU Besancon - Pneumologie

Besançon, France

Bordeaux - Polyclinique Nord

Bordeaux, France

Caen - Centre François Baclesse

Caen, France

Caen - CHU Côte de Nacre

Caen, France

Chartres, France

Cholet, France

CHU

Clermont-Ferrand, France

Colmar, France

...and 28 more locations