Partial-Breast Radiation Therapy in Treating Women With Early-Stage Breast Cancer
A Single Institution, Prospective, Non-randomized Study of Partial Breast Irradiation Using the MammoSite Radiation Therapy System (Breast Brachytherapy Applicator)
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. It may also cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well partial-breast radiation therapy works in treating women with early-stage breast cancer.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
OBJECTIVES:
Primary
- To examine the efficacy of MammoSite® Radiation Therapy System (RTS) in delivering partial-breast irradiation to women with early-stage breast cancer.
Secondary
- To assess the toxicities associated with MammoSite® RTS in these patients.
- To evaluate the cosmetic results in the breast after brachytherapy with the MammoSite® RTS.
- To correlate the cosmetic results with the use of chemotherapy, volume of the implant, and distance from the implant to the skin.
- To correlate the local recurrence rate with time between surgery and implant.
OUTLINE: Patients undergo placement of the MammoSite® Radiation Therapy System (RTS) device into the cavity where the tumor was removed either at the time of surgery or percutaneously under ultrasound guidance after surgery. Within 2-5 days after the device implant, patients undergo partial-breast irradiation delivered by MammoSite® RTS twice daily for 5 days.
After completion of study therapy, patients are followed up periodically for 5 years.
Tipo de estudio
Fase
- Fase 2
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Histologically confirmed ductal carcinoma in situ (DCIS) of the breast or invasive breast adenocarcinoma
- Stage 0, I, or II (T2, N0; tumor size ≤ 3 cm) disease
Pathologic staging of the axilla preferred
- Clinical staging of the axilla allowed for patients ≥ 70 years of age with hormone receptor-positive tumors
Unicentric tumor
- Microscopic multifocality allowed as long as the total tumor size is ≤ 3 cm
Must have undergone lumpectomy as definitive surgery
Negative surgical margins, defined as no tumor at the inked margin of resection after final surgery
- Re-excision to obtain negative margins allowed
- Must have adequate skin spacing between balloon surface and surface of the skin and lung (≥ 7 mm)
- No multicentric carcinoma (invasive or DCIS) in more than one quadrant
- No clinically or pathologically positive regional lymph nodes
- No extensive intraductal component, defined as DCIS extending beyond the primary invasive component into normal breast parenchyma and composing > 25% of the primary tumor
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
No collagen-vascular disease, including any of the following:
- Dermatomyositis
- Systemic lupus erythematosus
- Scleroderma-mixed connective tissue disease
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
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)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of local recurrence
Periodo de tiempo: up to 5 years
|
|
up to 5 years
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Safety and toxicity
Periodo de tiempo: up to 30 months after radiotherapy
|
up to 30 months after radiotherapy
|
|
Cosmetic results
Periodo de tiempo: up to 30 months
|
up to 30 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Edward Kim, MD, Ohio State University Comprehensive Cancer Center
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
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
Otros números de identificación del estudio
- OSU-08177
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