- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01340495
Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy
Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Proton radiation will be delivered daily for approximately 5 1/2 weeks. Patients will be assessed weekly for any side effects they may be experiencing.
Patients will have follow-up visits 4 weeks after proton therapy ends, at 6 months, 12 months, and then every year for up to five years after treatment. Follow-up visits will include a physical examination, radiological imaging (if necessary), echocardiogram, and laboratory tests.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Histologically confirmed invasive breast cancer confined to the breast and regional lymphatics
- Completed mastectomy (complete not partial )breast surgery +/- reconstructive surgery
- Life expectancy > 12 months
Exclusion Criteria:
- Pregnant or breast-feeding
- Prior therapeutic radiation > 200 cGy
- History of a different malignancy unless disease-free for at least 5 years or diagnosed and treated cervical cancer in situ, or basal or squamous cell cancer of the skin
- Prior investigation chemotherapy
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: Proton Radiation
Radiation therapy with proton beam
|
45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event
Periodo de tiempo: From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks
|
To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy based on the occurrence of grade 3 or > radiation pneumonitis or any grade 4 adverse event within 3 months after the completion of radiation treatment.
|
From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The Number of Participants With Acute Skin Toxicities
Periodo de tiempo: From the start of treatment until 3 months after the end of treatment
|
Summary of the number of participants with any grade acute skin toxicities.
Acute skin toxicity was assessed from the start of treatment until 90 days after the end of treatment.
Skin toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
|
From the start of treatment until 3 months after the end of treatment
|
Rate and Severity of Radiation Pneumonitis
Periodo de tiempo: From the start of treatment until 3 months after the end of treatment and was not included in the analysis population.
|
The number of participants that experienced radiation pneumonitis within three months of the end of treatment. The participants that experienced radiation pneumonitis are grouped by grade. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
|
From the start of treatment until 3 months after the end of treatment and was not included in the analysis population.
|
Summary of Late Skin Toxicity
Periodo de tiempo: From 3 months after the end of treatment up to 5 years
|
A summary of the late skin toxicities experienced by participants.
The number of participants effected is shown for each toxicity experienced.
Skin toxicities were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
|
From 3 months after the end of treatment up to 5 years
|
To Evaluate Cosmetic Outcome and Patient Satisfaction With Cosmetic Outcome
Periodo de tiempo: From the start of treatment until 5 years post treatment
|
From the start of treatment until 5 years post treatment
|
|
Acute and Late Toxicity of Breast Reconstruction Following Proton Radiation
Periodo de tiempo: From the start of treatment until 5 years post treatment
|
Combined summary of the acute (within 3 months of completing treatment) and late (3 months to 5 years after completion of treatment) toxicities experienced by participants thought to be related to breast reconstruction surgery following proton radiation treatment.
Toxicities are assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
|
From the start of treatment until 5 years post treatment
|
The Number of Participants That Needed Unplanned Additional Surgery for Breast Reconstruction
Periodo de tiempo: From the start of treatment until 5 years post treatment
|
From the start of treatment until 5 years post treatment
|
|
The Number of Participants With Early Signs of Cardiac Effects From Radiation Therapy
Periodo de tiempo: Baseline and then 4 and 8 weeks post treatment
|
The number of participant that had early signs of cardiac effects from radiation therapy as assessed using a Strain Echo-cardiogram.
The data from the Echo-cardiogram was evaluated for signs of negative impacts to cardiac function as determined by the treating physician.
Parameters considered in the evaluation of the echo-cardiogram by the physician included myocardial velocity, strain, strain rate, and torsion.
Blood-based cardiac bio-markers pro-BNP and ultra-sensitive troponin-I were also assessed.
Either a clinically meaningful change in the strain echo-cardiogram parameters or clinically meaningful elevation of the bio-markers was sufficient to be considered to have early signs of cardiac effects.
|
Baseline and then 4 and 8 weeks post treatment
|
Progression Free Survival
Periodo de tiempo: from the start of treatment until the time of disease progression, up to 5 years
|
Progression-free survival is defined as the duration from the start of radiation to the date of objective disease progression or death due to any cause, whichever is earlier.
Disease progression is defined as the appearance of one or more new lesions.
|
from the start of treatment until the time of disease progression, up to 5 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Shannon M MacDonald, M.D., Massachusetts General Hospital
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
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
Otros números de identificación del estudio
- 10-205
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 mama invasivo
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated Hospital of Zhengzhou University y otros colaboradoresTerminadoLa guía de aplicación clínica de Conebeam Breast CTPorcelana
-
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
Ensayos clínicos sobre Proton Radiation
-
Washington University School of MedicineReclutamientoCáncer metastásico | Tumor sólido irresecableEstados Unidos
-
University of FloridaTerminadoCáncer de mamaEstados Unidos
-
Loma Linda UniversityTerminadoCancer de pancreasEstados Unidos