A Registry Study of Permanent Breast Seed Implant
22 de octubre de 2021 actualizado por: Dr. Eric Leung, Sunnybrook Health Sciences Centre
A Multicentre Registry Study of Permanent Breast Seed Implant (PBSI) for Early Stage Breast Cancers.
Women found to have early stage breast cancer will have their cancer surgically removed followed by radiation treatment to the entire breast, five times per week for several weeks. The radiation treatment prevents the cancer from growing back but creates skin burns. Several studies have showed that it is nor necessary treating the whole breast.
The investigators team has pioneered a new therapy realizing the permanent implantation of tiny radioactive seeds into the surgical cavity in a single one hour procedure under light anesthesia. Patients live a normal life while receiving the radiation treatment. The results of a first clinical trial on 67 patients shows that the treatment is well tolerate and efficient. The purpose of the study is to offer the treatment in several places and to increase the cohort of patient to 420 to capture rare complications if any.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
For early stage breast cancer, accelerated partial breast irradiation is an alternative treatment option to whole breast irradiation after breast conserving surgery. Our group has previously reported results of a Phase I/II study of permanent breast seed implant (PBSI) using palladium-103 seeds as an alternative to whole breast radiotherapy for well selected breast cancer patients. The procedure is realised in a single session under light sedation and local freezing. After a median FU of 54 months no patients has recurred on a cohort of 67 patients, and acute of delayed side effect compared favourably to external beam radiotherapy.
Yet this study was a single centre study and the sample size did not allow evaluating appropriately the risk of serious adverse events (SAE). The current study propose evaluating SAE on a multicentre and larger cohort of 420 patients.
Tipo de estudio
Intervencionista
Inscripción (Actual)
420
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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Ontario
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Toronto, Ontario, Canadá, M4N3M5
- Sunnybrook Odette Cancer Centre
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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:
- A confirmed histological diagnosis of invasive breast carcinoma
- Treated by breast conserving surgery with axillary node dissection (with a minimum of 6 nodes sampled) or sentinel lymph node biopsy
- Surgical margins clear over or equal to 2 mm
- A maximum tumor size of 3 cm
- Age >= 50 years old
- ECOG performance status of 0 or 1
- Informed consent signed
Exclusion Criteria:
- Previous history of cancer other than curable skin SCC or Tis or T1 cervix
- Patient receiving anti-coagulant that cannot be stopped two weeks prior PBSI
- Autoimmune disorder
- Diabetes insulin-dependant
- Pregnancy
- Breast implants
- Psychiatric or addictive disorder that would preclude attending follow-up
- Post-operative breast infection
- Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign)
- Lobular features on histology (pure or mixed) or sarcoma histology
- Node positive on axillary dissection or in the sentinel lymph node biopsy
- Extensive in situ carcinoma
- Multicentric disease (in more than one quadrant or separated by 2 cm or more)
- Paget's disease of the nipple
- Metastases
- Patients presenting a post-surgical fluid cavity ≥ 2.5 cm in diameter in any dimension as determined on the planning US
- Clear delineation of the target volume on CT is not possible
- Having a volume to be implanted over 120cc
- Having a target volume too close to skin such that the 85% isodose overlaps the skin surface)
- Having a target volume too close to the chest wall, such that there is a risk of perforating the chest wall
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 |
|---|---|
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Experimental: PBSI
PBSI is a form of accelerated partial breast irradiation involving the insertion of 103-palladium stranded seeds under ultra-sound guidance and light sedation after CT planning in lieu of whole breast adjuvant radiotherapy.
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Patients are pre-planned using CT simulation.
Implant is realised under light sedation and local freezing.
Stranded seeds are inserted using a brachytherapy template that is immobilised to the planned target volume using a 'localization' needle.
Patients is released the same day and Quality Assurance involves a 2 months post-implant CT
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Serious Adverse Events
Periodo de tiempo: Initial and then yearly up to 5 years
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Serious Adverse Events (SAE) is an unintended sign, symptom, or syndrome illness that occurs during the period of observation in the clinical study and that is life threatening or result in death.
SAE will be coded using the NCI CTC V3.0 scale and corresponds to grade 4 or 5 signs or symptoms.
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Initial and then yearly up to 5 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Breast cancer local recurrence
Periodo de tiempo: Yearly up to 10 years
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Ipsilateral in-breast or chest wall recurrence is defined as evidence of invasive or in situ breast cancer (except LCIS) in the ipsilateral breast.
Patients will have a biopsy of the suspicious lesion to confirm the diagnosis with documentation of the location.
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Yearly up to 10 years
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Regional recurrence
Periodo de tiempo: Yearly up to 10 years
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Regional recurrence is defined as the development of tumor in regional nodes as well as the soft tissue of the ipsilateral axilla after axillary dissection.
The regional recurrence is suspected on imaging and/or clinical symptoms and must be documented with fine needle aspiration.
Also the localisation of the nodal recurrence must be reported (internal mammary chain, supra-clavicular area or axilla).
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Yearly up to 10 years
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Metastases
Periodo de tiempo: Yearly up to 10 years
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Distant recurrence is defined as evidence of tumor in any area of the body.
The metastasis recurrence should be proved by appropriate imaging, biopsy or fine needle aspiration
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Yearly up to 10 years
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PBSI side effects
Periodo de tiempo: After procedure
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Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
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After procedure
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PBSI side effects
Periodo de tiempo: At 2 months
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Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
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At 2 months
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PBSI side effect
Periodo de tiempo: At 6 months
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Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
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At 6 months
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PBSI side effect
Periodo de tiempo: Yearly up to 10 years
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Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
Fat necrosis will be diagnosed either by mammography or clinically (prolonged indurations and pain in the area of seeds implantation without evidence of infection).
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Yearly up to 10 years
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Cosmetic outcome
Periodo de tiempo: Yearly up to 10 years
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Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist.
An excellent cosmetic result score is assigned when the treated breast looked essentially the same as the contralateral breast (as it relates to radiation effects).
A good cosmetic score is assigned for minimal but identifiable radiation effects of the treated breast.
A fair score means significant radiation effects were readily observable.
A poor score is used for severe sequelae of breast tissue secondary to radiation effects.
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Yearly up to 10 years
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Survival
Periodo de tiempo: Yearly up to 10 years
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Patient survival, either free of cancer or with disease present will be recorded at follow-up appointments.
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Yearly up to 10 years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Eric Leung, MD, Sunnybrook Health Sciences Centre
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Pignol JP, Keller B, Rakovitch E, Sankreacha R, Easton H, Que W. First report of a permanent breast 103Pd seed implant as adjuvant radiation treatment for early-stage breast cancer. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):176-81. doi: 10.1016/j.ijrobp.2005.06.031. Epub 2005 Sep 22.
- Keller BM, Pignol JP, Rakovitch E, Sankreacha R, O'Brien P. A radiation badge survey for family members living with patients treated with a (103)Pd permanent breast seed implant. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):267-71. doi: 10.1016/j.ijrobp.2007.08.006. Epub 2007 Oct 29.
- Keller B, Sankreacha R, Rakovitch E, O'brien P, Pignol JP. A permanent breast seed implant as partial breast radiation therapy for early-stage patients: a comparison of palladium-103 and iodine-125 isotopes based on radiation safety considerations. Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):358-65. doi: 10.1016/j.ijrobp.2004.10.014.
- Pignol JP, Rakovitch E, Keller BM, Sankreacha R, Chartier C. Tolerance and acceptance results of a palladium-103 permanent breast seed implant Phase I/II study. Int J Radiat Oncol Biol Phys. 2009 Apr 1;73(5):1482-8. doi: 10.1016/j.ijrobp.2008.06.1945. Epub 2008 Oct 18.
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 marzo de 2009
Finalización primaria (Actual)
19 de enero de 2018
Finalización del estudio (Actual)
19 de enero de 2018
Fechas de registro del estudio
Enviado por primera vez
9 de abril de 2010
Primero enviado que cumplió con los criterios de control de calidad
19 de abril de 2010
Publicado por primera vez (Estimar)
20 de abril de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de octubre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
22 de octubre de 2021
Última verificación
1 de octubre de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PBSI Registry
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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