- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03743324
Effect of Radiation and Its Timing on Breast Reconstruction in Chinese Patients
14 de noviembre de 2018 actualizado por: Tianjin Medical University Cancer Institute and Hospital
A Multi-center Prospective Observational Trial Investigating the Effect of Radiation and Its Timing on Breast Reconstruction in Chinese Patients
The purpose of the study is to investigate the impacts of radiation and the timing of radiation on autologous and prosthetic-based breast reconstruction in Chinese post-mastectomy breast cancer patients.
The study aims to optimize the timing for autologous/prosthetic breast reconstruction which delivers the best aesthetic results while maintains low complication rate and best integrates into the comprehensive breast cancer treatment.
The study is open to all female breast cancer patients undergoing breast reconstruction in the department of breast reconstruction in Tianjin medical university cancer institute and hospital.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
In breast cancer patients, post-operative radiation therapy is an important component in breast cancer management.
However, in the context of breast reconstruction, radiation can have adverse effect as it increases the rate of fat necrosis and leads to fibrosis/ capsular contracture in the reconstructed breast mounds.
It is therefore necessary to investigate the best timing for breast reconstruction, especially in those patients which post-operative radiation is required, which does not interfere with overall breast cancer treatment while produces the best surgical, aesthetic and psychological outcome.
Most studies in this field are retrospective, and studies on Chinese cohort are also rare.
This multi-center prospectively designed clinical trial will include several medical centers across China.
The investigators will allocate the patients into three arms based on the status and sequence of radiation and breast reconstruction, and will further stratify the groups based on the different approaches of reconstruction (autologous/ prosthetic based).
Both objective and subjective (patient oriented) methods will be employed to make evaluations involving surgical, aesthetic, and psychological outcomes.
Tipo de estudio
De observación
Inscripción (Anticipado)
1344
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.
Estudio Contacto
- Nombre: Shanshan He
- Número de teléfono: 1174 +86-22-23340123
- Correo electrónico: ssh85@yahoo.com
Copia de seguridad de contactos de estudio
- Nombre: Jian Yin
- Número de teléfono: 1171 +86-22-23340123
- Correo electrónico: yinjian@tjmuch.com
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
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Método de muestreo
Muestra no probabilística
Población de estudio
Study population include female Chinese breast cancer patients who wish to undergo autologous or prosthetic-based breast reconstruction.
Descripción
Inclusion Criteria:
- Diagnosed with breast cancer
- Karnofsky Performance Status (KPS) larger than 70
- Underwent autologous or prosthetic based breast reconstruction
- No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.
Exclusion Criteria:
- Metastatic breast cancer
- Local recurrence after mastectomy
- Prior radiation history to chest wall due to other tumors
- Radiation performed more than 6 months after mastectomy
- Interruption of radiation more than 2 weeks
- Gravida or during lactation
- Concurrently undergoing psychotic disorders
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
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
BR group
Breast reconstruction without radiation therapy
|
Immediate Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer
Delayed Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer
|
Immediate BR +post-op radiation
Immediate breast reconstruction followed by surgical site radiation therapy
|
Immediate Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer
Radiation is performed to the surgical site and complies with the ASCO guidelines on post-mastectomy radiotherapy
|
Radiation +delayed BR
previous post-mastectomy radiation followed by delayed breast reconstruction
|
Delayed Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer
Radiation is performed to the surgical site and complies with the ASCO guidelines on post-mastectomy radiotherapy
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
occurrence of short term complications
Periodo de tiempo: the short term complications will be inspected up to 3 months post-op;
|
impaired arterial or venous flap perfusion by increased (>3 seconds) or reduced (<2 seconds) capillary refill time; infection of the reconstructed breast with evidences from microbiological cultures; partial or entire flap necrosis with evident demarcation by clinical observation
|
the short term complications will be inspected up to 3 months post-op;
|
occurrence and change of long term complications
Periodo de tiempo: the long term complications will be assessed at 6 months post-op; repeated assessments will be made at 12 and 24 months to record changes
|
fat necrosis proven by breast ultrasound/ breast MRI/ pathology; flap contracture that causes change in shape and/or volume in the reconstructed breast mound observed by naked-eye inspection or breast imaging; capsular contracture that causes hardness/pains or changes of the reconstructed breast mound observed by surgeon's inspection or breast imaging.
|
the long term complications will be assessed at 6 months post-op; repeated assessments will be made at 12 and 24 months to record changes
|
occurrence of secondary surgery
Periodo de tiempo: up to 24 months post-op
|
unplanned surgery due to short-term and/or long-term complications post-op, the types of secondary surgery include but not limited to exploratory surgery, flap salvages, removal or fat necrosis, debridement, prosthetic explantation.
|
up to 24 months post-op
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
occurrence of revision surgery
Periodo de tiempo: 6 to 24 months post-op
|
any surgery performed to the reconstructed or contralateral breast to optimize symmetry
|
6 to 24 months post-op
|
baseline and change of subjective evaluation
Periodo de tiempo: the baseline evaluation will be made at 6 months post-op; repeated evaluations will be made at 12 and 24 months to record changes
|
patient oriented aesthetic, psychological and overall outcome evaluations are made with BREAST-Q (short for breast-questionnaire) post reconstruction module, the the selected questionnaire includes a set of questions regarding : category 1-patients' satisfaction with breasts; category 2-patients' satisfaction with outcome and category 3-patients' psychological well-being.
In each category, the total score is generated by Q-score (short for questionnaire-score)software and the total score ranges from 0-100.
The higher the score the better the satisfaction.
|
the baseline evaluation will be made at 6 months post-op; repeated evaluations will be made at 12 and 24 months to record changes
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Jian Yin, Tianjin Medical University Cancer Institute and Hospital
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
- Barry M, Kell MR. Radiotherapy and breast reconstruction: a meta-analysis. Breast Cancer Res Treat. 2011 May;127(1):15-22. doi: 10.1007/s10549-011-1401-x. Epub 2011 Feb 20.
- Schaverien MV, Macmillan RD, McCulley SJ. Is immediate autologous breast reconstruction with postoperative radiotherapy good practice?: a systematic review of the literature. J Plast Reconstr Aesthet Surg. 2013 Dec;66(12):1637-51. doi: 10.1016/j.bjps.2013.06.059. Epub 2013 Jul 22.
- Berbers J, van Baardwijk A, Houben R, Heuts E, Smidt M, Keymeulen K, Bessems M, Tuinder S, Boersma LJ. 'Reconstruction: before or after postmastectomy radiotherapy?' A systematic review of the literature. Eur J Cancer. 2014 Nov;50(16):2752-62. doi: 10.1016/j.ejca.2014.07.023. Epub 2014 Aug 26.
- Kelley BP, Ahmed R, Kidwell KM, Kozlow JH, Chung KC, Momoh AO. A systematic review of morbidity associated with autologous breast reconstruction before and after exposure to radiotherapy: are current practices ideal? Ann Surg Oncol. 2014 May;21(5):1732-8. doi: 10.1245/s10434-014-3494-z. Epub 2014 Jan 29.
- Losken A, Nicholas CS, Pinell XA, Carlson GW. Outcomes evaluation following bilateral breast reconstruction using latissimus dorsi myocutaneous flaps. Ann Plast Surg. 2010 Jul;65(1):17-22. doi: 10.1097/SAP.0b013e3181bda349.
- Selber JC, Kurichi JE, Vega SJ, Sonnad SS, Serletti JM. Risk factors and complications in free TRAM flap breast reconstruction. Ann Plast Surg. 2006 May;56(5):492-7. doi: 10.1097/01.sap.0000210180.72721.4a.
- Chang EI, Liu TS, Festekjian JH, Da Lio AL, Crisera CA. Effects of radiation therapy for breast cancer based on type of free flap reconstruction. Plast Reconstr Surg. 2013 Jan;131(1):1e-8e. doi: 10.1097/PRS.0b013e3182729d33.
- Kronowitz SJ. Current status of implant-based breast reconstruction in patients receiving postmastectomy radiation therapy. Plast Reconstr Surg. 2012 Oct;130(4):513e-523e. doi: 10.1097/PRS.0b013e318262f059.
- Pestana IA, Campbell DC, Bharti G, Thompson JT. Factors affecting complications in radiated breast reconstruction. Ann Plast Surg. 2013 May;70(5):542-5. doi: 10.1097/SAP.0b013e31827eacff.
- Chatterjee JS, Lee A, Anderson W, Baker L, Stevenson JH, Dewar JA, Thompson AM. Effect of postoperative radiotherapy on autologous deep inferior epigastric perforator flap volume after immediate breast reconstruction. Br J Surg. 2009 Oct;96(10):1135-40. doi: 10.1002/bjs.6693.
- Rogers NE, Allen RJ. Radiation effects on breast reconstruction with the deep inferior epigastric perforator flap. Plast Reconstr Surg. 2002 May;109(6):1919-24; discussion 1925-6. doi: 10.1097/00006534-200205000-00022.
- Yueh JH, Slavin SA, Adesiyun T, Nyame TT, Gautam S, Morris DJ, Tobias AM, Lee BT. Patient satisfaction in postmastectomy breast reconstruction: a comparative evaluation of DIEP, TRAM, latissimus flap, and implant techniques. Plast Reconstr Surg. 2010 Jun;125(6):1585-1595. doi: 10.1097/PRS.0b013e3181cb6351.
- Lam TC, Hsieh F, Boyages J. The effects of postmastectomy adjuvant radiotherapy on immediate two-stage prosthetic breast reconstruction: a systematic review. Plast Reconstr Surg. 2013 Sep;132(3):511-518. doi: 10.1097/PRS.0b013e31829acc41.
- He S, Yin J, Robb GL, Sun J, Zhang X, Li H, Liu J, Han C. Considering the Optimal Timing of Breast Reconstruction With Abdominal Flaps With Adjuvant Irradiation in 370 Consecutive Pedicled Transverse Rectus Abdominis Myocutaneous Flap and Free Deep Inferior Epigastric Perforator Flap Performed in a Chinese Oncology Center: Is There a Significant Difference Between Immediate and Delayed? Ann Plast Surg. 2017 Jun;78(6):633-640. doi: 10.1097/SAP.0000000000000927.
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 (Anticipado)
1 de enero de 2019
Finalización primaria (Anticipado)
1 de noviembre de 2022
Finalización del estudio (Anticipado)
1 de abril de 2023
Fechas de registro del estudio
Enviado por primera vez
7 de noviembre de 2018
Primero enviado que cumplió con los criterios de control de calidad
14 de noviembre de 2018
Publicado por primera vez (Actual)
16 de noviembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de noviembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
14 de noviembre de 2018
Última verificación
1 de noviembre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- E2018210
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
There is no plan to share IPD with other researchers.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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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