Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Pemetrexed

Cetuximab

Cisplatin

Antineoplastic Agents, Immunological

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

Chemotherapy

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

ERBITUX

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

Radiotherapy

Jean Trédaniel, MD, PhD

Françoise Mornex, MD, PhD

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.

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)

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).

Percentage of patient alive 18 months after registration

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.

Intergroupe Francophone de Cancerologie Thoracique

Chemotherapy + cetuximab + radiotherapy

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

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

Chemoradiotherapy + Cetuximab

Chemoradiotherapy

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

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

Age, Continuous

Sex: Female, Male

France

Region of Enrollment

Smoker

Per the 7th edition of UICC/AJCC staging system. The T staging is determined by the size of primary tumour in long axis, or direct extent of the tumour into adjacent structures such as mediastinum or chest wall. The N classification descibes the degree of spread to regional lymph nodes. This remained unchanged in the 7th edition as the new data showed no change in node staging related survival. The M staging defines the presence of metastases beyond regional lymph nodes.

Stage IIIA: T1 to T3N2M0 and T4N1M0; Stage IIIB: T1 to T4N3M0, Stage IV: T1 to T4 N1toN3 M1

Stage

Histological subtype

PS0 : fully active, able to carry on all pre-disease performance without restriction PS1 : Restricted in physically strenuous but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work, office work

Spots Global Cancer Trial Database for Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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