- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02059967
Phase I IGART Study Using Active Breathing Control and Simultaneous Boost for Patients With NSCLC
A Phase I Image-Guided Adaptive Radiotherapy Study Using Active Breathing Control (ABC) and Simultaneous Integrated Boost for Patients With Inoperable Non-Small Cell Lung Cancer
Descripción general del estudio
Estado
Condiciones
- Cáncer 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 de células no pequeñas en estadio IIB
Intervención / Tratamiento
Descripción detallada
OUTLINE: This is a dose-escalation study of IGART.
Patients undergo IGART using active breathing control (ABC) 5 days a week for 7 weeks, for a total of 33 fractions with simultaneous integrated volume adapted boost (SIVAB) during fractions 26-33. Patients also receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 30 minutes once a week for 6 weeks.
After completion of study treatment, patients are followed up periodically for 5 years.
Tipo de estudio
Fase
- Fase 1
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Histologically-proven (by biopsy or cytology), unresectable or inoperable lung cancer of the following histologic types: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, non-small cell carcinoma not otherwise specified.
- The tumor stage must be Stage IIA-IIIB (AJCC 7th edition). See http://aboutcancer.com/AJCC 7th lung 1.gif and http://aboutcancer.com/AJCC 7th lung 2.gif for staging.
- All detectable tumor must be encompassed by radiation therapy fields.
- 18-fluorodeoxyglucose PET is required for staging and treatment planning.
- Atelectasis, if present, must involve less than a complete lung.
Laboratory values:
- Neutrophils >1500/µL
- Platelets >100,000/µL
- Bilirubin < 1.5 mg/dL
- Aspartate aminotransferase (AST; formerly serum glutamic oxaloacetic transaminase [SGOT]) < 2x upper limit normal
- Alanine aminotransferase (ALT; formerly serum glutamic pyruvic transaminase [SGPT]) < 2x upper limit normal
- Serum creatinine < 2.0 mg/dL
- Glomerular filtration rate (GFR) calculated (kidney function test) within 30 days must be ≥ 59 mL/min
- Pulmonary function test (PFT) with FEV-1 ≥ 1.0 L/sec
- Plan of curative radiotherapy with or without concurrent chemotherapy.
- Karnofsky Performance Scale score of ≥ 70%.
- Age ≥ 18 years old.
- Measurable disease on the planning CT.
Patient must have a completed IMRT plan to 66 Gy in 2 Gy fractions with ≥ 95% of the PTV covered by the prescription dose, and the attending physician must have reviewed and approved the DVHs as follows:
- total lung V20 Gy ≤ 30%
- mean esophageal dose ≤ 34 Gy
- esophageal planning organs-at-risk volume (PRV) V60 Gy ≤ 30%
- heart V40 Gy ≤ 50%
- maximum brachial plexus dose ≤ 66 Gy
- maximum spinal cord PRV dose ≤ 50 Gy
- maximum aorta dose ≤ 66 Gy
- maximum main bronchus dose ≤ 66 Gy
- maximum dose ≥ 66 Gy allowed in only one lobar bronchus.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
- Prior radiation therapy to the thorax.
- Previous chemotherapy or previous biologic response modifiers for current lung cancer or within the past 5 years.
- Clinically significant pleural effusions, pericardial effusions, or superior vena cava syndrome.
- Oxygen supplementation required during therapy.
- Involvement of the brachial plexus, or infiltration of the aorta, heart, or esophagus.
- Tumors that affect more than one lobar bronchus, except the second involved bronchus in the right middle lobe bronchus.
- Unable to perform the BH procedures, unless tumor motion is ≤ 3 mm.
- Myocardial infarction within the last 6 months, symptomatic heart disease, uncompensated chronic obstructive pulmonary disease (COPD), or uncontrolled bronchospasms.
- History of a prior malignancy from which the patient has not been disease free for a minimum of 2 years, other than adequately treated basal/squamous skin cancer or in situ cervix cancer or other in situ malignancy.
- Pregnant or lactating women.
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: Treatment (IGART using ABC, SIVAB, paclitaxel, carboplatin)
Patients undergo IGART using ABC 5 days a week for 7 weeks, for a total of 33 fractions with SIVAB during fractions 26-33.
Patients also receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once a week for 6 weeks.
|
Dado IV
Otros nombres:
Dado IV
Otros nombres:
Someterse a IGART
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
MTD, defined as the highest dose level at which =< 3 out of 7 patients experience a dose-limiting toxicity
Periodo de tiempo: 3 months
|
(using daily image-guidance, deformable image registration, adaptive replanning at defined time points, and dose intensification at normal tissue tolerance) of radiotherapy delivered concomitantly with standard chemotherapy.
|
3 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Incidence of acute toxicity measured using the National Cancer Institution Common Terminology for Adverse Events version 4.0
Periodo de tiempo: Up to 90 days from radiation therapy start
|
Toxicities associated with higher dose per fraction during the SIVAB phase of the protocol will be tabulated and analyzed with respect to treatment dose, respective normal tissue structure and dose-volume parameters.
|
Up to 90 days from radiation therapy start
|
Incidence of late toxicity measured using the Radiation Therapy Oncology Group Late Radiation Morbidity Scoring
Periodo de tiempo: Up to 5 years
|
Toxicities associated with higher dose per fraction during the SIVAB phase of the protocol will be tabulated and analyzed with respect to treatment dose, respective normal tissue structure and dose-volume parameters.
|
Up to 5 years
|
Practicability of the approach
Periodo de tiempo: Up to 5 years
|
Variations in respiratory patterns, tumor and CTV positions, as well as tumor volumes will be assessed on the respective under-treatment imaging studies.
The feasibility of deformable image registration will be benchmarked against manual contours of targets and normal tissue.
The practicability of IGART will be measured by assessing the necessary time, IT and personnel resources needed to conduct the study.
|
Up to 5 years
|
Tumor response evaluated according to Response Evaluation Criteria in Solid Tumors v1.1
Periodo de tiempo: Up to 15 years
|
Up to 15 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Elisabeth Weiss, MD, Virginia Commonwealth University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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 por tipo histológico
- Neoplasias
- Enfermedades pulmonares
- Neoplasias por sitio
- Adenocarcinoma
- Carcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Neoplasias Pulmonares
- Carcinoma de pulmón de células no pequeñas
- Adenocarcinoma de pulmón
- 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
- MCC-13-09209
- HM20000101 (Otro identificador: IRB)
- MCC-20000101 (Otro identificador: VCU Massey Cancer Center)
- NCI-2014-00163 (Identificador de registro: NCI)
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. .
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