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
Collecte de données
Néoplasmes bronchiques+7
+ Carcinome du poumon non à petites cellules
+ Carcinome bronchogénique
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mai 2004
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.598 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 28 sites
Azienda Ospedaliera - Universitaria di Modena
Modena, ItalyAzienda Ospedaliera Maggiore Della Carita
Novara, ItalyAzienda Ospedale S. Luigi at University of Torino
Orbassano, Italy