T1-T2 Breast Cancer: Comparison Between Removal and Preservation of Axillary Lymph Nodes (SINODAR ONE) (SINODAR ONE)
16. december 2021 opdateret af: Fondazione Humanitas per la Ricerca
T1-T2 Breast Cancer: Comparison Between Removal and Preservation of Axillary Lymph Nodes in the Presence of Sentinel Lymph Node Metastases (SINODAR ONE)
Italian Multicentric non inferiority two-arm randomized clinical trial to verify that the experimental treatment (omission of axillary lymph node intervention) in the presence of sentinel lymph node metastases does not lead to a significant worsening in survival or in the risk of locoregional recurrence compared to standard treatment (removal of I-II level of axillary lymph nodes).
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Detailed Description:
The trial is a non-inferiority trial; patients, depending on intra-operative or post-operative sentinel lymph node assessment, are randomly assigned to one of the two intervention groups:
group 1: removal of I-II level of axillary lymph nodes (standard treatment). Removal of at least 10 lymph nodes is recommended.
group 2: no axillary lymph nodes dissection (experimental treatment). Patients for whom sentinel lymph node cannot be found, will undergo complete dissection of the axillary cavity as required by international guidelines.
After surgery, according to their bio-pathological profile and to the international guidelines criteria, patients will be able to receive:
- no further treatment
- complementary radiotherapy
- adjuvant medical therapy (chemo and / or hormone therapy).
Patients will be checked for at least 5 years in the following ways:
- six-monthly clinical examination for the first 5 years and yearly thereafter
- mammography + annual breast ultrasound
- annual axillary ultrasound in cases not subjected to dissection.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
889
Fase
- Ikke anvendelig
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
40 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Age: 40 ≤75 years old
- Breast cancer with infiltrating histology
- Tumor size ≤50 mm (T1 - T2)
- Clinically and ultrasound node-negative (cN0) breast cancer
- No distant metastases (M0)
- No neoadjuvant therapy
- Negative history of previous infiltrating neoplasm
- Maximum number of metastatic sentinel lymph nodes: 2
- Lymph node macro-metastases > 2mm
Exclusion Criteria:
- Pregnancy or breastfeeding in progress
- Inflammatory breast cancer
- Breast cancer in situ
- Synchronous contralateral breast cancer
- Co-morbidities such as to preclude the possible use of adjuvant therapy
- Conditions that make it impossible to carry out a regular follow-up
- Other malignancies within the previous 3 years (except carcinoma in situ of the uterine cervix, basalioma or squamous cell ca or non-melanoma skin ca)
- Breast cancer with non-infiltrating or inflammatory histotype
- Tumor size> 50 mm
- No sentinel lymph nodes identified
- No positive sentinel lymph nodes (pN0)
- Positive sentinel lymph node number > 2
- Lymph node micro-metastases <= 2
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Axillary dissection (standard treatment)
Axillary dissection in women with sentinel lymph node metastases. (removal of at least 10 lymph nodes recommended) |
Axillary dissection in patients with positive sentinel lymph node
|
|
Eksperimentel: Preservation of axillary lymph nodes
Omission of Axillary dissection in women with sentinel lymph node metastases.
|
Preservation of axillary lymph nodes in patients with positive sentinel lymph node
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: 5 years of follow up after surgery
|
Evaluating whether, in women operated for breast cancer (T1-T2) with sentinel lymph node metastases, axillary lymph node conservation is associated with a clinically relevant prognostic worsening (OS).
For all the Outcomes Statistical analysis included Kaplan-Meier Product Limit Estimator and the log-rank test
|
5 years of follow up after surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Regional Disease Free Survival (RDFS)
Tidsramme: 5 years of follow up after surgery
|
Evaluating whether axillary lymph node preservation is associated with a clinically relevant increase of local recurrence rate (ipsilateral axillary and supraclavicular lymph nodes).
|
5 years of follow up after surgery
|
|
Disease-free distance survival (DDFS)
Tidsramme: 5 years of follow up after surgery
|
Evaluating whether axillary lymph node preservation is associated with a clinically relevant increase in distant recurrence rate.
|
5 years of follow up after surgery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Corrado Tinterri, MD, Istituto Clinico Humanitas
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 (Faktiske)
14. april 2015
Primær færdiggørelse (Forventet)
30. april 2025
Studieafslutning (Forventet)
30. april 2025
Datoer for studieregistrering
Først indsendt
19. november 2021
Først indsendt, der opfyldte QC-kriterier
2. december 2021
Først opslået (Faktiske)
16. december 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. januar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. december 2021
Sidst verificeret
1. december 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1317
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