- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01646346
4D Image-Guided Partial Breast Radiation in Stage 0 and l Breast Cancer
25 de octubre de 2018 actualizado por: Yale University
A Pilot Study of Four-Dimensional Conformal Image Guided Accelerated Partial Breast Irradiation In The Treatment Of Stage 0 and l Breast Cancer
The Purpose of this study is to evaluate the feasibility of using image guidance and four-dimensional computed tomography to reduce the volume of non target breast tissue that is treated with accelerated partial breast irradiation via the external beam technique.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a pilot study enrolling about 30 patients to evaluate the feasibility of using 4D CT and daily image guidance in Accelerated Partial Breast Irradiation (APBI) to decrease set-up error and individualized planning target volumes to limit the non-target breast tissue dose.
The two specific breasts constraints which shall be decreased are the V50 (percent volume of breast receiving 50% of the prescribed dose) and the V100 (percent volume of breast receiving 100% of the prescribed dose).
The goal will be to decrease these to 45% and 23.5% respectively, which is down 33% from the NSABP B39 standard of 60% and 35%.
Tipo de estudio
Intervencionista
Inscripción (Actual)
46
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
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06510
- Smilow Cancer Hospital Care Center, Yale New Haven Hospital
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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
50 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- The patient must consent to be in the study and must have a signed an approved consent form conforming with institutional guidelines.
- Patient must be > 50 years old.
- The patient should have a life expectancy of at least two years with a karnofsky performance status > 70.
- The patient must have stage 0 or I breast cancer.
- On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.
- Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (>2mm, DCIS and invasive). Re-excision of surgical margins is permitted.
- Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 2 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 2 cm or less.)
- Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes or axillary dissection alone (with a minimum of 6 axillary nodes). Axillary staging is NOT required for patients with DCIS.
- The patient must have simulation within 8 weeks/56 days of the final surgery for their breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure).
- Patients with a history of non-ipsilateral breast malignancies are eligible if they have been disease-free for 2 or more years prior to enrollment. Patients with the following cancers are eligible even if diagnosed and treated within the past 2 years: carcinoma in situ of the cervix, colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
- Chemotherapy is permitted if planned for ≥ 2 weeks after radiation.
- Urine pregnancy test must be performed and be negative on all women younger than 60 who have not had a tubal ligation, oophorectomy, or hysterectomy.
- Separate incisions for the lumpectomy and sentinel node biopsy should be present. Use of only one incision will typically result in a contiguous cavity with the tumor bed and the sentinel node sampling, and inability of the radiation oncologist to delineate the tumor bed from the sentinel node bed.
- The patient must have a cavity which is able to be targeted with external beam APBI, either through surgical clip placement, or CVS 3 or higher. The cavity to whole breast ratio must be 30% or less.
Exclusion Criteria:
- Men are not eligible for this study as men are not breast conservation candidates.
- T0, T2 (> 2.0 cm), T3, node positive, stage III or IV breast cancer.
- Any positive axillary nodes.
- Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless biopsy proven to be negative for tumor.
- Suspicious microcalcifications, densities or palpable abnormalities in either breast unless biopsy proven to be benign.
- Non-epithelial breast malignancies such as sarcoma or lymphoma.
- Proven multicentric carcinoma in more than one quadrant or separated by more than 2 centimeters.
- Paget's disease of the nipple.
- History of invasive breast cancer or DCIS in the same breast.
- Surgical margins that cannot be microscopically assessed or are less then 2 mm.
- Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.
- Pregnancy or lactation at the time of proposed radiation. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
- Psychiatric or addictive disorders or other conditions that, in the opinion of the treating physician, would preclude the patient from meeting the study requirements.
- Patients with coexisting medical conditions in whom life expectancy is < 2 years.
- Patients with skin involvement, regardless of tumor size.
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: 4D Conformal Image-Guided Partial Breast RT
This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.
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External beam partial breast radiation to target a portion of the breast twice a day for 5 days.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Patients With Reduction in Incidental Radiation
Periodo de tiempo: 5 day
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Patients were assessed to determine if there was a reduction in breast radiation V50 less than 45% and V100 less than 23.5%.
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5 day
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Cosmesis by Patient Report
Periodo de tiempo: Within no more than 8 weeks of surgery, but prior to the start of radiation
|
This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS).
Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome).
Scores on each item are summed to obtain a total score.
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Within no more than 8 weeks of surgery, but prior to the start of radiation
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Cosmesis by Patient Report
Periodo de tiempo: 1 year post treatment
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This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS).
Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome).
Scores on each item are summed to obtain a total score.
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1 year post treatment
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Cosmesis by Patient Report
Periodo de tiempo: 3 year post treatment
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This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS).
Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome).
Scores on each item are summed to obtain a total score.
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3 year post treatment
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Cosmesis by Medical Doctor Report
Periodo de tiempo: Within no more than 8 weeks of surgery, but prior to the start of radiation
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Medical doctor will be provided with cosmesis scale and grade cosmesis of breast.
Cosmesis was based on the Harvard Cosmesis Scale rated as :1.
excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae.
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Within no more than 8 weeks of surgery, but prior to the start of radiation
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Cosmesis by Medical Doctor Report
Periodo de tiempo: 1 yr post treatment
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Medical doctor will be provided with cosmesis scale and grade cosmesis of breast.
Cosmesis was based on the Harvard Cosmesis Scale rated as :1.
excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae.
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1 yr post treatment
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Cosmesis by Medical Doctor Report
Periodo de tiempo: 3 yr post treatment
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Medical doctor will be provided with cosmesis scale and grade cosmesis of breast.
Cosmesis was based on the Harvard Cosmesis Scale rated as :1.
excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae.
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3 yr post treatment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Suzanne Evans, MD, Yale University
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 (Actual)
10 de enero de 2012
Finalización primaria (Actual)
17 de julio de 2017
Finalización del estudio (Actual)
17 de julio de 2017
Fechas de registro del estudio
Enviado por primera vez
11 de marzo de 2012
Primero enviado que cumplió con los criterios de control de calidad
18 de julio de 2012
Publicado por primera vez (Estimar)
20 de julio de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de noviembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
25 de octubre de 2018
Última verificación
1 de octubre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1110009173
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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