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An Evaluation of Cosmetic Results and Toxicity in the Use of Post-Mastectomy Immediate Reconstruction With a Tissue Expander and Acellular Dermal Matrix Followed by Radiation Therapy

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

post-mastectomy radiation therapy (PMRT)

+ tissue expander (TE)

+ acellular dermal matrix (ADM)

RadiaciónDispositivo
Quiénes están siendo reclutados

Enfermedades de la Mama+2

+ Neoplasias

+ Neoplasias por Sitio

A partir de 18 años
+14 Criterios de eligibilidad
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Cómo está diseñado el estudio

Estudio de Tratamiento

Intervencional
Inicio del estudio: septiembre de 2009
Ver detalles del protocolo

Resumen

Patrocinador PrincipalDana-Farber Cancer Institute
Última actualización: 26 de agosto de 2019
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de septiembre de 2009

Fecha en la que se inscribió al primer participante.

ADMs have been used in combination with a tissue expander and radiotherapy but have not been studied formally in terms of their ability to avoid complications sometimes seen with other methods of reconstruction and improve the delivery of the radiation. The only difference between being on the study and not being on the study is that the research team will analyze the records of those who participate to see how easy it was to give the radiation, how good the cosmetic outcome of the reconstruction is and what, if any, complications occured. A minimum of 6 weeks between the surgery and the start of radiation therapy is required to allow for adequate healing. Often this interval will be longer, as many patients will receive chemotherapy in the interim. There is no maximum time from surgery to radiation. Around the time of radiation planning, the radiation oncologist and plastic surgeon will agree upon how much deflation of the tissue expander will be required to permit simulation of the radiation therapy. Radiation therapy to the chest wall (with or without adjacent lymph nodes) will be given once daily Monday through Friday over 5-7 weeks. After the completion of the radiation therapy, the tissue expander will be re-expanded and eventually replaced by the permanent implant or flap reconstruction at the discretion of the plastic surgeon. Participants will be expected to return to the Radiation Oncology Clinic for follow-up visits 6, 12, 18 and 24 months after the end of the radiation therapy. Evaluation of cosmetic results and complications will be done at these visits using a recognized scoring system and photographs taken at each time point and scored for specific items (necrosis, telangiectasia, etc).

Patrocinador PrincipalDana-Farber Cancer Institute
Última actualización: 26 de agosto de 2019
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 32 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades de la MamaNeoplasiasNeoplasias por SitioEnfermedades de la PielNeoplasias de la Mama

Criterios

8 criterios de inclusión requeridos para participar
18 years of age or older

Axillary nodes may be positive or negative

Microscopically positive margins are permitted

Participants must be candidates for postmastectomy radiation therapy (RT). Postmastectomy RT routinely is indicated for patients with pathologically-staged T3N1 (or higher stage) tumors, T1-T2 tumors with 4 or more positive nodes, some T1-T2 tumors with 1-3 positive nodes, and, infrequently, for some N0 tumors

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6 criterios de exclusión impiden participar
HIV-positive individuals on combination antiretroviral therapy

Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin

Participants with T4 tumors

Participants with recurrent breast cancer or a history of prior breast RT

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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Participants received immediate breast reconstruction using a sub-muscular tissue expander (TE) and acellular dermal matrix (ADM) sling placed during the same surgery. This was followed by post-mastectomy radiation therapy (PMRT) no sooner than a minimum of 6 weeks and optimally 6 months, if adjuvant chemotherapy was required. The prescribed chest-wall dose was 50 -50.4 gray (Gy) in 25-28 fractions given once daily over 5-7 weeks with a 0.5-centimeter (cm) bolus to the scar every other day. Permanent reconstruction was performed at least 5 months after completion of PMRT.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 2 ubicaciones

Brigham and Women's Hospital

Boston, United StatesAbrir Brigham and Women's Hospital en Google Maps

Dana-Farber Cancer Institute

Boston, United States
Completado2 Centros de Estudio