A Randomized Phase III Study of Follow Up With or Without Adjuvant Gefitinib (Iressa™) Following Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
Colección de datos
Carcinoma de pulmón no microcítico+7
+ Carcinoma broncogénico
+ Neoplasias bronquiales
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 2004
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary * Compare overall survival of patients with stage IIIB or IV non-small cell lung cancer that did not progress on prior first-line palliative induction chemotherapy when treated with adjuvant gefitinib vs placebo. Secondary * Compare progression-free survival of patients treated with these regimens. * Determine the safety and toxicity of gefitinib in these patients. OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to initial disease stage (IIIB vs IV), WHO performance status at the end of prior first-line palliative induction chemotherapy (0-1 vs 2), best patient response to prior first-line palliative induction chemotherapy (objective response vs stable disease), and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral gefitinib once daily. * Arm II: Patients receive oral placebo once daily. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 598 patients (299 per treatment arm) will be accrued for this study within 8.5 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 598 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer meeting 1 of the following stage criteria: * Stage IIIB * Pleural fluid and/or supraclavicular nodes allowed provided patient is not eligible for consolidation radiotherapy * Stage IV disease * No disease progression after 2-6 courses of prior platinum-containing first-line palliative induction chemotherapy * Brain metastases allowed provided patients are asymptomatic after cranial irradiation completed at least 4 weeks ago PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Pulmonary * No history, signs, or symptoms of clinically active interstitial lung disease * Patients with chronic, stable, asymptomatic radiographic changes are eligible Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up * No other malignant disease within the past 5 years except basal cell skin cancer or adequately treated superficial carcinoma of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy Chemotherapy * See Disease Characteristics * Recovered from prior chemotherapy (alopecia allowed) * No concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics Surgery * Not specified Other * No prior epidermal growth factor receptor inhibitors * No concurrent administration of any of the following drugs: * Phenytoin * Carbamazepine * Rifampin * Phenobarbital * Hypericum perforatum (St. John's wort) * No other concurrent anticancer therapy * No other concurrent experimental drugs
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 28 ubicaciones
Azienda Ospedaliera - Universitaria di Modena
Modena, ItalyAzienda Ospedaliera Maggiore Della Carita
Novara, ItalyAzienda Ospedale S. Luigi at University of Torino
Orbassano, Italy