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

3. april 2018 opdateret af: Yongsheng Wang, Shandong Cancer Hospital and Institute

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.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Shandong
      • Jinan, Shandong, Kina, 250117
        • Shandong Cancer Hospital and Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Andre navne:
  • 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.
Andre navne:
  • ALND
Procedure: Pathological Evaluation
H&E and IHC
Medicin: Adjuvant Systemic Therapy
Adjuvant systemic therapy was determined by the treating physician according to the recently NCCN.
Andre navne:
  • chemotherapy or hormone therapy
Stråling: Radiation Therapy
Whole-breast opposing tangential-field radiation therapy.
Eksperimentel: 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.
Andre navne:
  • SLNB
Procedure: Intraoperative Pathological Examination
touch imprint cytology and/or frozen section and/or OSNA
Procedure: Pathological Evaluation
H&E and IHC
Medicin: Adjuvant Systemic Therapy
Adjuvant systemic therapy was determined by the treating physician according to the recently NCCN.
Andre navne:
  • chemotherapy or hormone therapy
Stråling: Radiation Therapy
Whole-breast opposing tangential-field radiation therapy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Disease Free Survival
Tidsramme: Time to relapse or progression up to 10 years
Time from randomization to relapse or death.
Time to relapse or progression up to 10 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival
Tidsramme: Time to death up to 10 years
Time from randomization to date of death.
Time to death up to 10 years
Axillary Recurrence Rate
Tidsramme: Time to local relapse up to 10 years
Estimate the incidence of axillary recurrence after surgery followed by axillary dissection or after surgery alone.
Time to local relapse up to 10 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shandong Cancer Hospital and Institute

Efterforskere

  • Ledende efterforsker: Jiong Wu, MD, Fudan University
  • Ledende efterforsker: Tao Ouyang, MD, Beijing Cancer Hospital and Institute
  • Ledende efterforsker: Feng-xi Su, MD, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Ledende efterforsker: Hong-yuan Li, MD, First Affiliated Hospital of Chongqing Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2013

Primær færdiggørelse (Forventet)

1. december 2025

Studieafslutning (Forventet)

1. juni 2026

Datoer for studieregistrering

Først indsendt

19. februar 2013

Først indsendt, der opfyldte QC-kriterier

20. februar 2013

Først opslået (Skøn)

21. februar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. april 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. april 2018

Sidst verificeret

1. april 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Z0011-China

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Kliniske forsøg med Brystkræft

Kliniske forsøg med Sentinel Lymph Node Biopsy

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