Projects / Programmes
Varovalna bezgavka (Slovene)
| Code |
Science |
Field |
Subfield |
| 3.04.00 |
Medical sciences |
Oncology |
|
| Code |
Science |
Field |
| B520 |
Biomedical sciences |
General pathology, pathological anatomy |
sentinel node, breast cancer
Researchers (9)
Organisations (1)
| no. |
Code |
Research organisation |
City |
Registration number |
No. of publicationsNo. of publications |
| 1. |
0302 |
Institute of Oncology Ljubljana |
Ljubljana |
5055733000 |
15,472 |
Abstract
The hypothesis is tested that by use of new technology of sentinel node biopsy, sentinel node positive patients with breast cancer can be effectively selected for either axillary dissection or radiotherapy of the axilla, whereas sentinel lymph node negative patients can be adequately followed without further treatment of the axilla. Approximmately 60 to 70% of all axillary staging operations could be made redunant. The primary aim is to reduce the morbidity of axillary treatment with equal good regional control and without loss of prognostic information. Secondary end points are axillary, shoulder and arm morbidity, quality of life, costs related to each procedure.
This is a phase III study comparing a complete axillary node dissection versus radiotherapy to the axilla in sentinel node positive patients , whereas sentinel node negative patients will be followed for the endpoints of the study as well.
The concerned patients will have an operable breast cancer less than 3 cm , without clinical suspect regional lymph nodes. Patients will have FNA or core biopsy proven unifocal invasive breast cancer and should be fit to undergo either treatments. Patients will be randomly assigned after preoperative randomisation (EORTC centre- Brussels) in case of positive sentinel nodes between complete axillary lymph node dissection and radiotherapy of the axilla. Sentinel node biopsies will be performed by the combined technique using preoperative lymphoscintigraphy by intra - or peritumoral injections of 99Tc Nanocoloid, immediate preoperative injection of Patent Blue Dye and sentinel node retrieval by both discoloration and intraoperative use of detection probes. If no sentinel node is found, patients will undergo a complete axillary lymph node dissection.
Before patient randomisation, informed consent must be given according to EU/GCP and national/local regulations.
Before starting a study each team composed of surgeon, nuclear physician and pathologist should perform at least thirty sentinel node procedures followed by a complete axillary lymph node dissection. At least in 26 patients the sentinel node has to be retrieved. Not more than one false negative should be encountered.
Adjuvant systemic therapy will be given to the patients needed according to the conclusions in St. Gallen.
The recruitment time will take 3 years, follow up after the last patient 5 years.
The trial is carried by EORTC Breast Cancer Cooperative Group and our group will take part in it.
