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External-Beam Partial-Breast Irradiation for Early Breast Cancer 40 Gy QD Over 2 Weeks

12 de octubre de 2020 actualizado por: Alphonse Taghian, MD, PhD, Massachusetts General Hospital

A Phase I Study of Once-Daily External-Beam Partial-Breast Irradiation (PBI) for Selected Patients With Early Invasive N0 or Non-Invasive Breast Cancer

Standard therapy for patients with early stage breast cancer consists of surgery to remove the cancer followed by radiation therapy. One question regarding radiation therapy for early stage breast cancer is whether the entire breast needs to be radiated or only a more limited area surrounding the tumor. Whole-breast irradiation (WBI) is radiation therapy given to the whole breast. Partial-breast irradiation (PBI) is radiation therapy given only to the area of the breast where the cancer was removed (called the "tumor bed").

The investigators hope the option of PBI will reduce side effects from radiation therapy and shorten the radiation treatment process when compared to WBI, since only part of the breast is being treated. The investigators also hope that this will make such treatment more convenient for breast cancer patients.

The purpose of the study is to evaluate the the safety of external-beam PBI in selected early breast cancer patients utilizing PBI in ten daily fractions over two weeks. The investigators will also evaluate the local control and the cosmetic results.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

After signing the consent form, the following will be assessed.

-CT scan of the breast that had the cancer removed to help plan the radiation therapy. This is referred to as a CT-simulation. This scan is done routinely as part of the regular treatment.

PBI Study Treatment: You will be given PBI once daily over 10 treatment days (Mon-Fri) over a 2 week period. During this time you will have a weekly interview, physical examination, and your skin will be assessed for any side effects of the radiation.

PBI will begin between 4 weeks to 3 months after breast surgery or 2-6 weeks after chemotherapy (if you have been given chemotherapy).

After the final dose of the study:

You will have the following scheduled follow-up visits: one at the completion of the radiation, once or twice during weeks 3-9 after the completion of radiation, once every 6 months for five years, and then once every year for the following five years after the completion of radiation therapy.

Tipo de estudio

Intervencionista

Inscripción (Actual)

54

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Estados Unidos, 02215
        • Massachusetts General Hospital
      • Boston, Massachusetts, Estados Unidos, 02215
        • Beth Isreal Deaconness Medical Center
      • Boston, Massachusetts, Estados Unidos, 02215
        • Brigham and Women's Hosptial

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Unicentric Stage I invasive ductal breast cancer or Grade I or II DCIS measuring less than or equal to 2cm on pathology and/or mammography
  • Histologically negative tumor margin 2 mm or more from any inked edges, or no tumor in a re-excision specimen or final shaved specimen
  • Clips must be placed in the lumpectomy cavity at the time of final excision in order to aid in the delineation of the tumor cavity at the time of simulation and radiation delivery

Exclusion Criteria:

  • No distant metastasis
  • Not pregnant or breastfeeding
  • No diffuse suspicious microcalcifications
  • No prior radiation therapy to the ipsilateral or contralateral breast or thorax
  • No histologic evidence of lymphovascular invasion (LVI)
  • No histologic evidence of EIC
  • No history of cosmetic or reconstructive breast surgery
  • No psychiatric illness that would prevent the patient from giving informed consent
  • No medical conditions that, in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient
  • No other currently active second malignancy other than non-melanoma skin cancers

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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: Partial Breast Irradiation
Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks
Radiación: External Beam Partial-Breast Irradiation
40 Gy in ten daily fractions over two weeks

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks
Periodo de tiempo: 2 years

The safety of external-beam PBI in selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions over two weeks. The study will be deemed too toxic if >10% of enrolled patients have at least one of the following outcomes within 24 months of completion of PBI.

  1. Grade 3 or 4 skin/subcutaneous or pulmonary toxicity.
  2. The development of clinical fat necrosis.
  3. The development of rib fracture on the ipsilateral treated side, detected either clinically and/or radiographically.

The data is shown as the number of participants that experienced each of the specific toxicities.
2 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Local Control Rates
Periodo de tiempo: 2 years
The local control rates (analyzed separately for patients with DCIS and invasive cancer). Local control is defined as lack of recurrence in the treated breast and ipsilateral axillary, supraclavicular and internal mammary lymph nodes. Recurrence is defined as the regrowth of tumor cells left following initial therapy and/or the development of new primary tumors unrelated to the original one. DCIS stands for 'Ductal Carcinoma In Situ'.
2 years
Distant Control Rates
Periodo de tiempo: 2 years
The number of participants that achieved distant control. Distant control is defined as a lack of distant metastasis following the completion of treatment. Distant metastasis refers to the development of disease at distant body sites like the lung, liver, bone, or brain.
2 years
Breast Cosmesis
Periodo de tiempo: End of treatment, 4-9 weeks post treatment, every six months for first 5 years, then annually for 5 years

Breast Cosmesis was assessed using a cosmetic scoring system. The data shown represent the latest assessment for each participant at the time of analysis. Cosmetic changes were assessed using the following the following criteria.

  • Excellent: Little or no observable change
  • Good: Minimal but identifiable changes
  • Fair: Significant results of radiotherapy noted
  • Poor: Severe normal tissue sequelae
End of treatment, 4-9 weeks post treatment, every six months for first 5 years, then annually for 5 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Massachusetts General Hospital

Colaboradores

Beth Israel Deaconess Medical Center
Brigham and Women's Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de mayo de 2012

Finalización primaria (Actual)

1 de agosto de 2016

Finalización del estudio (Actual)

1 de agosto de 2019

Fechas de registro del estudio

Enviado por primera vez

11 de enero de 2012

Primero enviado que cumplió con los criterios de control de calidad

18 de abril de 2012

Publicado por primera vez (Estimar)

20 de abril de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de noviembre de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

12 de octubre de 2020

Última verificación

1 de octubre de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 11-351

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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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