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Axillary Lymph Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node (Z0011-China)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Shandong Cancer Hospital and Institute
Sponsor:
Information provided by (Responsible Party):
Yongsheng Wang, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier:
NCT01796444
First received: February 19, 2013
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Procedure: Sentinel Lymph Node Biopsy
Procedure: Intraoperative Pathological Examination
Procedure: Axillary Lymph Node Dissection
Procedure: Pathological Evaluation
Drug: Adjuvant Systemic Therapy
Radiation: Radiation Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Shandong Cancer Hospital and Institute:

Primary Outcome Measures:
  • Disease Free Survival [ Time Frame: Time to relapse or progression up to 10 years ] [ Designated as safety issue: No ]
    Time from randomization to relapse or death.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Time to death up to 10 years ] [ Designated as safety issue: No ]
    Time from randomization to date of death.

  • Axillary Recurrence Rate [ Time Frame: Time to local relapse up to 10 years ] [ Designated as safety issue: No ]
    Estimate the incidence of axillary recurrence after surgery followed by axillary dissection or after surgery alone.


Estimated Enrollment: 4
Study Start Date: January 2013
Estimated Study Completion Date: June 2026
Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Procedure: Sentinel Lymph Node Biopsy
Sentinel lymph nodes are identified with the combining use of intraoperative gamma detector and/or blue dye.
Other Name: SLNB
Procedure: Intraoperative Pathological Examination
touch imprint cytology and/or frozen section and/or OSNA
Procedure: Axillary Lymph Node Dissection
Axillary lymph node dissection involving removal of at least level I and II nodes.
Other Name: ALND
Procedure: Pathological Evaluation
H&E and IHC
Drug: Adjuvant Systemic Therapy
Adjuvant systemic therapy was determined by the treating physician according to the recently NCCN.
Other Name: chemotherapy or hormone therapy
Radiation: Radiation Therapy
Whole-breast opposing tangential-field radiation therapy.
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.
Procedure: Sentinel Lymph Node Biopsy
Sentinel lymph nodes are identified with the combining use of intraoperative gamma detector and/or blue dye.
Other Name: SLNB
Procedure: Intraoperative Pathological Examination
touch imprint cytology and/or frozen section and/or OSNA
Procedure: Pathological Evaluation
H&E and IHC
Drug: Adjuvant Systemic Therapy
Adjuvant systemic therapy was determined by the treating physician according to the recently NCCN.
Other Name: chemotherapy or hormone therapy
Radiation: Radiation Therapy
Whole-breast opposing tangential-field radiation therapy.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796444

Contacts
Contact: Yong-sheng Wang, MD +8653167626211 wangysh2008@yahoo.com.cn

Locations
China, Shandong
Shandong Cancer Hospital and Institute Recruiting
Jinan, Shandong, China, 250117
Contact: Yong-sheng Wang, MD    +8613505409989    wangysh2008@yahoo.com.cn   
Contact: Peng-fei Qiu, MD    +8615168872002    qiupengfei2002@yahoo.cn   
Principal Investigator: Yong-sheng Wang, MD         
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Investigators
Study Chair: Yong-sheng Wang, MD Shandong Cancer Hospital and Institute
Principal Investigator: Tao Ouyang, MD Beijing Cancer Hospital and Institute
Principal Investigator: Jiong Wu, MD Fudan University
Principal Investigator: Feng-xi Su, MD Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Principal Investigator: Hong-yuan Li, MD First Affiliated Hospital of Chongqing Medical University
  More Information

No publications provided

Responsible Party: Yongsheng Wang, Director, Head of Breast Cancer Center, Principal Investigator, Clinical Professor, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT01796444     History of Changes
Other Study ID Numbers: Z0011-China
Study First Received: February 19, 2013
Last Updated: February 20, 2013
Health Authority: China: Ministry of Health

Keywords provided by Shandong Cancer Hospital and Institute:
Breast Cancer
Sentinel Lymph Node Biopsy
Axillary Lymph Node Dissection

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 27, 2014