- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01486602
Specialized Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Phase I Study of Accelerated Hypofractionated Radiation Therapy With Concomitant Chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVES:
I. To determine the maximum-tolerable radiotherapy (RT) dose fraction for accelerated hypofractionated radiotherapy with concurrent chemotherapy.
SECONDARY OBJECTIVES:
I. To evaluate the rate of radiographic response to treatment. II. To estimate the rates of progression: local/regional/distant. III. To estimate the progression-free survival. IV. To estimate the overall survival.
OUTLINE: This is a dose-escalation study of accelerated hypofractionated radiotherapy.
CONCURRENT THERAPY: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60 minutes on days 1 and 8. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo accelerated hypofractionated radiotherapy using 3-dimensional conformal radiation therapy or intensity-modulated radiotherapy (IMRT) once daily, 5 days a week, for approximately 4-5.5 weeks.
CONSOLIDATION THERAPY: Beginning 4 weeks after completion of radiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 month, every 3 months for 2 years, and then every 6 months for 3 years.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Arizona
-
Phoenix, Arizona, Estados Unidos, 85054
- Mayo Clinic Hospital
-
Scottsdale, Arizona, Estados Unidos, 85259
- Mayo Clinic Scottsdale
-
-
California
-
La Jolla, California, Estados Unidos, 92093-0987
- Moores University of California San Diego Cancer Center
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60637
- University of Chicago
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21201
- University of Maryland/Greenebaum Cancer Center
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02215
- Dana Farber Cancer Institute
-
-
New York
-
Syracuse, New York, Estados Unidos, 13210
- State University of New York Upstate Medical University
-
-
North Carolina
-
Chapel Hill, North Carolina, Estados Unidos, 27599-7305
- University of North Carolina - Chapel Hill
-
Winston-Salem, North Carolina, Estados Unidos, 27157-1030
- Wake Forest University Health Sciences
-
-
Rhode Island
-
Providence, Rhode Island, Estados Unidos, 02903
- Rhode Island Hospital
-
-
Vermont
-
Burlington, Vermont, Estados Unidos, 05401
- University of Vermont
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
- Histologically or cytologically documented non-small cell lung cancer
- Stage IIIA or IIIB non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) version 7; patients who present with N2 or N3 disease and an undetectable primary tumor are also eligible
- Thoracic disease without supraclavicular or contralateral hilar involvement
- When pleural fluid is visible on both computed tomography (CT) scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative; exudative pleural effusions are excluded regardless of cytology; patients with effusions that are minimal (i.e., not visible on chest x-ray) and too small to safely tap are eligible
- No prior radiotherapy or chemotherapy for NSCLC
- No prior mediastinal or thoracic radiotherapy
- Patients with complete surgical resection of disease are not eligible, however; patients with surgical resection and measurable gross residual disease present on imaging are considered eligible
Patients must have measurable disease
- Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral CT scan
Patients with non-measurable disease are not eligible; all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly nonmeasurable lesions; lesions that are considered non-measurable include the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- No patients that are known to be pregnant or nursing
- Granulocytes ≥ 1,500/μl Platelet count ≥ 100,000/μl Bilirubin ≤ 1.5 times upper limit of normal (ULN) Aspartate aminotransferase (AST) (serum glutamic oxalo-acetic transaminase [SGOT]) ≤ 2.0 times ULN Serum creatinine ≤ 1.5 times ULN OR calculated creatinine clearance >= 70 mL/min FEV-1 ≥ 1.2 L/sec or 50% predicted
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Concurrent therapy + consolidation therapy
Concurrent Therapy (1 cycle = 14 days, Cycles 1-3): Patients will receive paclitaxel 45 mg/m^2 by IV over 1 hour weekly followed by carboplatin AUC 2 by IV over 30-60 minutes for 4 weeks (there will be no chemotherapy during Cycle 3). Patients will receive radiotherapy concurrently for up to 5.5 weeks, depending on the cohorts the patient is registered defined per the protocol. Consolidation Therapy (1 cycle = 21 days, Cycles 4-5): Four weeks following the end of radiotherapy patients will receive paclitaxel 200 mg/m^2 by IV over 3 hours followed by carboplatin AUC 6 by IV over 30-60 minutes on day 1 of each 21 day cycle for a total of 2 cycles (days 1 and 22). |
IV
IV
Defined per the protocol
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Maximum-tolerated RT dose fraction
Periodo de tiempo: Up to 28 months
|
Up to 28 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Supervivencia libre de progresión
Periodo de tiempo: Hasta 5 años
|
Hasta 5 años
|
Sobrevivencia promedio
Periodo de tiempo: Hasta 5 años
|
Hasta 5 años
|
Radiographic response
Periodo de tiempo: Up to 5 years
|
Up to 5 years
|
Metabolic response
Periodo de tiempo: Up to 5 years
|
Up to 5 years
|
Rates of progression: local/regional/distant
Periodo de tiempo: Up to 5 years
|
Up to 5 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: James J. Urbanic, MD, Wake Forest University Health Sciences
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Neoplasias
- Enfermedades pulmonares
- Neoplasias por sitio
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Neoplasias Pulmonares
- Carcinoma de pulmón de células no pequeñas
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos, fitogénicos
- Carboplatino
- Paclitaxel
Otros números de identificación del estudio
- CALGB 31102
- U10CA180821 (Subvención/contrato del NIH de EE. UU.)
- U10CA031946 (Subvención/contrato del NIH de EE. UU.)
- CDR0000719011 (Identificador de registro: Physician Data Query)
- NCI-2012-00087 (Identificador de registro: NCI Clinical Trial Reporting Program)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Cáncer de pulmón
-
Abramson Cancer Center of the University of PennsylvaniaTerminadoPaciente con cancerEstados Unidos
-
Peking Union Medical College HospitalTerminadoEncuesta | Estado nutricional | Paciente con cancerPorcelana
-
Ankara Medipol UniversityReclutamientoCuidados personales | Inmunoterapia | Manejo de síntomas | Paciente con cancerPavo
-
Northwestern UniversityGenzyme, a Sanofi CompanyRetiradoCANCER DE PROSTATAEstados Unidos
-
Fundacao ChampalimaudTerminado
-
University College London HospitalsTerminado
-
GenSpera, Inc.RetiradoCancer de prostata.Estados Unidos
-
University of Colorado, DenverColorado State UniversityRetiradoRealidad virtual | Diagnóstico por imagen | Educación del paciente | Paciente con cancerEstados Unidos
-
Dana-Farber Cancer InstituteTerminadoCancer de RIÑON | Cancer de prostata | Cáncer genitourinarioEstados Unidos
-
Rabin Medical CenterReclutamiento
Ensayos clínicos sobre carboplatino
-
Virginia Commonwealth UniversityNational Cancer Institute (NCI)RetiradoCáncer de pulmón de células no pequeñas en estadio IIIA | Cáncer de pulmón de células no pequeñas en estadio IIIB | Cáncer de pulmón de células escamosas | Adenocarcinoma de pulmón | Cáncer de pulmón de células grandes | Cáncer de pulmón de células no pequeñas en estadio IIA | Cáncer de pulmón...
-
Children's Oncology GroupNational Cancer Institute (NCI)TerminadoTumor cerebral | Tumor del sistema nervioso centralEstados Unidos, Canadá, Australia, Suiza, Países Bajos, Nueva Zelanda