A Phase II Randomized Trial With Captopril In Patients Who Have Received Radiation Therapy +/- Chemotherapy For Stage II-IIIB Non-Small Cell Lung Cancer, Stage I Central Non-Small Cell Lung Cancer, Or Limited-Stage Small-Cell Lung Cancer
captopril
Síndrome de Fibrosis por Radiación+12
+ Carcinoma de pulmón no microcítico
+ Carcinoma broncogénico
Estudio de Cuidados de Apoyo
Resumen
Fecha de inicio: 1 de junio de 2003
Fecha en la que se inscribió al primer participante.OBJECTIVES: * Determine the effect of captopril on the incidence of pulmonary damage at 12 months after radiotherapy with or without chemotherapy in patients with stage II-IIIB non-small cell lung cancer, stage I central non-small cell lung cancer, or limited stage small cell lung cancer. * Compare the quality of life of patients treated with captopril vs patients who undergo post-radiotherapy observation only. * Determine the persistence of captopril's effect on pulmonary toxicity in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, total lung irradiated (< 25% vs 25-37% vs more than 37%), prior surgery (yes vs no), and prior chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral captopril 3 times daily for 1 year in the absence of disease progression or unacceptable toxicity. * Arm II: Patients undergo observation only for 1 year. Quality of life is assessed at baseline and at months 3, 6, 12, and 18. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 205 patients will be accrued for this study within 18 months.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 81 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Cuidados de Apoyo
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: * One of the following histologically or cytologically confirmed diagnoses: * Stage II-IIIB non-small cell lung cancer (NSCLC) * Stage I central NSCLC * No peripheral coin lesions * Limited stage small cell lung cancer * Nonmetastatic disease that is receiving radiotherapy and the target is confined to a single radiotherapy treatment area * Planning to receive radiotherapy * At least 45 Gy to be delivered to the target volume * More than 25% of total lung volume to receive \> 20 Gy if receiving radiotherapy alone PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Hematopoietic * Absolute granulocyte count greater than 1,000/mm\^3 * Platelet count greater than 75,000/mm\^3 * Hemoglobin greater than 9.0 g/dL (transfusion allowed) Hepatic * Bilirubin less than 1.5 mg/dL * Serum glutamate oxaloacetate transaminase (SGOT) less than 2 times normal Renal * Blood urea nitrogen (BUN) less than 25 mg/dL * Creatinine less than 1.6 mg/dL * Urine protein less than 10 mg/dL * Urine glucose negative Cardiovascular * Systolic blood pressure greater than 110 mm Hg * Diastolic blood pressure greater than 60 mm Hg Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Sodium normal * Potassium normal * No collagen vascular disease (e.g., lupus or scleroderma) * Rheumatoid arthritis allowed * No known hypersensitivity to ACE inhibitors PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Induction or concurrent chemotherapy allowed either during radiotherapy or during therapy with captopril * No concurrent methotrexate Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics Surgery * Prior pulmonary lobectomy or segmentectomy allowed * No prior pneumonectomy Other * No concurrent angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor antagonists for hypertension or congestive heart failure * No concurrent lithium * No concurrent procainamide
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos 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 87 ubicaciones
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, United StatesVer ubicaciónMobile Infirmary Medical Center
Mobile, United StatesArizona Oncology Services Foundation
Phoenix, United StatesProvidence Saint Joseph Medical Center - Burbank
Burbank, United States