A Randomized Phase III Study Comparing Induction Chemotherapy to Daily Low Dose Cisplatin Both Combined With High Dose Radiotherapy Using Concomitant Boost Technique in Patients With Inoperable Non-Small Cell Lung Cancer Stage I, II, and Low Volume Stage III
cisplatin
+ gemcitabine hydrochloride
+ radiation therapy
Neoplasias bronquiales+7
+ Carcinoma broncogénico
+ Enfermedades del pulmón
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de febrero de 1999
Fecha en la que se inscribió al primer participante.OBJECTIVES: Compare survival, disease-free survival, local control, and pattern of recurrence in patients with unresectable stage I, II, or low-volume stage III non-small lung cancer treated with high-dose radiotherapy either preceded by induction chemotherapy with gemcitabine and cisplatin or combined with daily cisplatin. Compare the acute and late toxic effects of these regimens in these patients. Determine the quality of life of these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs 1), TNM stage, and participating center. Patients are randomized to one of two treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 3-6 hours on day 2. Treatment is repeated once 21 days later. Patients undergo high-dose accelerated conformal radiotherapy beginning on week 9 (day 57), 5 days a week, for 24 fractions, using a concurrent boost technique up to 66 Gy. Arm II: Patients receive low-dose cisplatin IV followed 1-2 hours later by high-dose accelerated conformal radiotherapy. Treatment continues daily, 5 days a week, for 24 fractions, using a concurrent boost technique up to 66 Gy. Quality of life is assessed before treatment and at weeks 9-11, 19, 27, and 35. Patients are followed at 3 weeks, 6-7 weeks, and then every 8 weeks thereafter. PROJECTED ACCRUAL: A total of 418 patients (209 per arm) will be accrued for this study within 5 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 158 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 Stage I, II, III (T1-4, N0-3, M0) No metastases to supraclavicular, contralateral hilar, or contralateral scalene lymph nodes Medically inoperable or unresectable No pleural or pericardial effusion (except with repeated negative cytology) PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 6.8 g/dL No hemoptysis causing a decrease of hemoglobin of 1 g/dL or more within 24 hours Hepatic: Not specified Renal: Creatinine no greater than 1.25 times normal OR Creatinine clearance greater than 70 mL/min Cardiovascular: No evidence of heart failure No myocardial infarction within the past 6 months No superior vena cava syndrome Pulmonary: FEV1 at least 1 L No pre-existing fibrotic lung disease No postobstructive pneumonia preventing exact delineation of tumor volume Diffusion capacity at least 60% Other: No weight loss of more than 10% in the past 3 months No uncontrolled infection No serious medical risk factors involving any of the major organ systems that would preclude adherence to the study treatment schedule PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the chest Maximum length of the esophagus receiving 40 Gy no greater than 18 cm Maximum length of the esophagus receiving 66 Gy no greater than 12 cm Must limit the spinal cord dose to a maximum of 50 Gy Must be able to exclude 25% of the heart from the boost volume Surgery: Not specified Other: No other concurrent experimental medications
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 17 ubicaciones
Hopital de Jolimont
Haine-Saint-Paul, BelgiumCHR de Grenoble - La Tronche
Grenoble, FranceMutterhaus der Borromaerinnen
Trier, Germany