Clinical Trials Logo
  1. Home
  2. Sentinel Lymph Node
  3. NCT04250129
  4. Details
NCT04250129 Clinical Trial

SENTINEL LYMPH NODE BIOPSY AFTER NEOADJUVANT CHEMOTHERAPY

Sentinel Lymph Node Clinical Trial

— NEOSENTITURK  

Official title:
IS SENTINEL LYMPH NODE BIOPSY WITH RADIOTHERAPY ALONE WITHOUT AXILLARY LYMPH NODE DISSECTION SAFE FOLLOWING NEOADJUVANT CHEMOTHERAPY IN INITIALLY CLINICALLY AXILLA POSITIVE PATIENTS: NEOSENTITURK-TRIAL/MF-18-03

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04250129
Other study ID # 2018-03
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 31, 2018
Est. completion date January 31, 2023

Study information
Verified date January 2020
Source Federation of Breast Diseases Societies
Contact Neslihan Cabioglu, Prof
Phone +905325057724
Email ncabioglu@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Omitting axilary lymph node dissection (ALND) following SLNB with residual cancer in patients with locally advanced disease after neoadjuvan chemotherapy (NAC) is still controversial. In this study, the investigators evaluated factors affecting local recurrence and outcome in patients with locally advanced breast cancer (LABC), who underwent sentinel lymph node (SLN) with or without ALND after NAC.

Description:

All patients with clinically positive axilla will undergo neoadjuvant chemotherapy. Axillary fine needle aspiration biopsy or Trucut biopsy is mandatory.

All patients with clinically node negativity (physical exam, USG, and/or MRI, PET-CT) after Neoadjuvant Chemotherapy (NAC) will be considered for SLNB with any technique (blue dye alone, radionuclide alone or both combined) and any breast surgery (mastectomy or breast conservation). PET-CT and MRI are not mandatory. PE and USG and/or MRI are preferred. At least, 2 sentinel lymph nodes will be obtained. Intraoperative evaluation of SLNs is recommended.

All patients with clinally-negative axilla and underwent SLNB will be included into the study:

1. SLNB (-) & RT

2. SLNB (+) & RT

3. SLNB (+) & ALND & RT Radiotherapy details will be announced as supplementary

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date January 31, 2023
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

T0-4, N1-3, M0

Exclusion Criteria:

Inflammatory breast cancer, pregnant patients Patients with metastatic disease

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Istanbul University Institute of Oncology Istanbul
Turkey Istanbul University Istanbul Faculty of Medicine Istanbul
Turkey Bulent Ecevit University Faculty of Medicine Zonguldak

Sponsors (1)
Lead Sponsor Collaborator
Federation of Breast Diseases Societies

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Local recurrence free survival Breast and axillary recurrence rates January 2023
Secondary Disease free survival Local recurrence and distant metastasis rates January 2023
Secondary Overall survival Overall survival January 2023
See also
  Status Clinical Trial Phase
Recruiting NCT05437380 - Peritumoral Microbubbles and CEUS for SLN Detection and Biopsy in HNSCC N/A
Active, not recruiting NCT04303715 - No Axillary sUrgical Treatment In Clinically Lymph Node Negative Patients After UltraSonography N/A
Completed NCT05498051 - Fluorescent Sentinel Lymph Node Identification in Colon Carcinoma Using Submucosal Bevacizumab-800CW. N/A
Active, not recruiting NCT06169787 - Sentinel Lymph Nodes Biopsy in Cervical Cancer
Completed NCT03294330 - SPY-X: A Study to Assess the Feasibility of Using SPY Alone for Sentinel Node Localization for Melanoma or Breast Cancer Phase 3
Not yet recruiting NCT04930692 - A Prospective Single-center Cohort Study "Preoperative Identification of Sentinel Lymph Nodes Using Contrast-enhanced CT Lymphography in Breast Cancer Patients" N/A
Recruiting NCT03749707 - HPV in Sentinel Lymph Nodes N/A
Completed NCT03899441 - Multimedia Aid Gynecologic Counseling and Consent N/A
Recruiting NCT04826211 - Axillary Staging in Node Positive Breast Cancer Patients Receiving PST. SNB vs PET/MRI N/A
Not yet recruiting NCT06130241 - Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Initially Node Positive Breast Cancer Patients, Could it Omit Axillary Dissection ? N/A
Recruiting NCT04664582 - Sentinel Lymph Node Biopsy for Cutaneous Squamous Cell Carcinoma of the Head and Neck N/A
Withdrawn NCT04487912 - Dynamics and Tracer Distribution of Tilmanocept in Early Stage Breast Cancer Phase 4
Completed NCT03563781 - SEntine Lymph Node in earLY Ovarian Cancer (SELLY) N/A
Recruiting NCT05623280 - Artificial Intelligence Analysis of Fluorescence Image to Intraoperatively Detect Metastatic Sentinel Lymph Node.
Active, not recruiting NCT05359783 - Sentinel Node Localization and Staging With Low Dose Superparamagnetic Iron Oxide Phase 1/Phase 2
Not yet recruiting NCT04568941 - Comparison Study of Different Tumor Biopsy Method for Sentinel Lymph Node Biopsy in Breast Cancer N/A
Completed NCT03606616 - Prospective Feasibility Study Applying the ACOSOG Z0011 Criteria to Chinese Patients
Recruiting NCT02982148 - Methylene Blue Intradermal Injection for Sentinel Lymph Node Biopsy for Breast Cancer Patients Phase 4
Recruiting NCT06161428 - Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer
Completed NCT03900104 - Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer N/A