Axillary Lymph Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node (Z0011-China)
A Prospective Randomized Multicenter Phase III Study of Axillary Lymph Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node--the Validation of Z0011 in China
The recently randomized trial (ASCOG Z0011) support that among patients with limited sentinel lymph node (SLN) metastatic breast cancer treated with breast conservation and systemic therapy, the use of sentinel lymph node biopsy (SLNB) alone compared with axillary lymph node dissection (ALND) did not result in inferior survival. These patients, therefore, are unlikely to benefit from further surgery that results in a longer period of hospitalization, higher costs and higher postoperative morbidity. This result has been written in the 2012 National Comprehensive Cancer Network Clinical Practice Guidelines.
However, Limitations of Z0011, such as failure to achieve target accrual and possible randomization imbalance favoring the SLNB-alone group, must be considered. In the other hand, further testing in different country are needed.
The investigators design and begin a prospective randomized multicenter phase III study of ALND vs. no ALND in breast Cancer with positive SLN--the validation of Z0011 in China.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
OBJECTIVES:
To determine the effects of complete axillary lymph node dissection (ALND) on survival of patients with sentinel lymph node (SLN) metastasis of breast cancer.
OUTLINE: This is a randomized multicenter study. Before randomization, all women were stratified according to age (≤50 years, >50 years), tumor size(≤2cm, >2cm) and research center. All the patients underwent lumpectomy and sentinel lymph node biopsy (SLNB). Eligible women were randomly assigned to ALND or no ALND Active Comparator: Patients undergo axillary lymph node dissection involving removal of at least level I and II nodes.
Experimental: No surgery of axillary lymph node in this arm. All the patients were to receive whole-breast opposing tangential-field radiation therapy. The use of adjuvant systemic therapy was determined by the treating physician according to the recently NCCN.
Patients are followed up every 4 months for the first 2 years, every 6 months from the third year to the fifth year, and then annually for a total of 10 years.
Tipo de estudio
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Shandong
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Jinan, Shandong, Porcelana, 250117
- Shandong Cancer Hospital and Institute
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Female;
- Patient aged 18 years and above;
- Patient with histological proven invasive breast cancer;
- Clinical T1-T2 disease with no distant metastasis;
- Patient with clinical N0 status;
- Patient for whom conservative surgery with sentinel lymph node (SLN) technique is feasible from the start in terms of carcinologic;
- Patient with positive SLNs 1~2;
- Signed consent to participate.
Exclusion Criteria:
- History of neoadjuvant chemotherapy or hormone therapy;
- History of breast cancer (ipsilateral, i.e. recurrence, or contralateral breast);
- History of any other invasive cancer;
- Initial metastatic disease known;
- Pregnant women or lactating women;
- Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Axillary Lymph Node Dissection
After sentinel lymph node biopsy, surgery for standard axillary lymph node dissection.
Pathological evaluation (include intraoperative pathological examination) is performed routinely.
All women were to receive whole-breast opposing tangential-field radiation therapy.
Adjuvant systemic therapy was determined by the treating physician.
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Sentinel lymph nodes are identified with the combining use of intraoperative gamma detector and/or blue dye.
Otros nombres:
touch imprint cytology and/or frozen section and/or OSNA
Axillary lymph node dissection involving removal of at least level I and II nodes.
Otros nombres:
H&E and IHC
Adjuvant systemic therapy was determined by the treating physician according to the recently NCCN.
Otros nombres:
Whole-breast opposing tangential-field radiation therapy.
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Experimental: Non-Axillary Lymph Node Dissection
After sentinel lymph node biopsy, no surgery of axillary lymph node In this study, the absence of surgery is the experimental arm (non-inferiority trial).
Pathological evaluation (include intraoperative pathological examination) is performed routinely.
All women were to receive whole-breast opposing tangential-field radiation therapy.
Adjuvant systemic therapy was determined by the treating physician.
|
Sentinel lymph nodes are identified with the combining use of intraoperative gamma detector and/or blue dye.
Otros nombres:
touch imprint cytology and/or frozen section and/or OSNA
H&E and IHC
Adjuvant systemic therapy was determined by the treating physician according to the recently NCCN.
Otros nombres:
Whole-breast opposing tangential-field radiation therapy.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Disease Free Survival
Periodo de tiempo: Time to relapse or progression up to 10 years
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Time from randomization to relapse or death.
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Time to relapse or progression up to 10 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Survival
Periodo de tiempo: Time to death up to 10 years
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Time from randomization to date of death.
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Time to death up to 10 years
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Axillary Recurrence Rate
Periodo de tiempo: Time to local relapse up to 10 years
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Estimate the incidence of axillary recurrence after surgery followed by axillary dissection or after surgery alone.
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Time to local relapse up to 10 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jiong Wu, MD, Fudan University
- Investigador principal: Tao Ouyang, MD, Beijing Cancer Hospital and Institute
- Investigador principal: Feng-xi Su, MD, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigador principal: Hong-yuan Li, MD, First Affiliated Hospital of Chongqing Medical University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Z0011-China
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