Ganglion sentinelle envahi : faut-il faire le curage ou pas ? Essai randomisé SERC |
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| Institution: | 1. Institut Paoli-Calmettes et CRCM 232, boulevard Sainte-Marguerite, 13273 Marseille cedex 9, France;2. Université Aix-Marseille, 27, bd Jean-Moulin, 13385 Marseille cedex 5, France;1. ELI-ALPS, ELI-HU Non-Profit Ltd., Dugonics tér 13, H-6720 Szeged, Hungary;2. Department of Theoretical Physics, University of Szeged, Tisza L. krt. 84-86, H-6720 Szeged, Hungary;3. Wigner Research Center for Physics, SZFI, PO Box 49, H-1525 Budapest, Hungary;1. Departamento de Dermatología, Facultad de Medicina, Universidad de Chile, Santiago, Chile;2. Servicio de Dermatología, Hospital Clínico Universidad de Chile, Santiago, Chile;1. AP–HP, Hôpital Lariboisière, Service de chirurgie digestive et oncologique, 2, rue Ambroise-Paré 75010 Paris, France;2. AP–HP, Hôpital Lariboisière, Université, René-Diderot Paris 7, UMR Inserm 965-Paris 7, CART : carcinose angiogenèse et recherche translationnelle, 2, rue Ambroise-Paré 75010 Paris, France;1. Department of Physics and Technology, Allegt. 55, University of Bergen, N-5007 Bergen, Norway;2. Physique du Rayonnement et des Interactions Laser-Matière, Faculté des Sciences, Université Moulay Ismail, B.P. 11201, Zitoune, Meknes, Morocco;3. Institute for Nuclear Research, Hungarian Academy of Sciences (Atomki), 4026 Debrecen Bem tér 18/c, Hungary;4. ELI-ALPS, ELI-HU Non-profit Kft., Dugonics tér 13, H-6720 Szeged, Hungary;5. Sorbonne Universités, UPMC Univ Paris 06, CNRS, Laboratoire de Chimie Physique-Matière et Rayonnement, F-75231 Paris Cedex 05, France |
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| Abstract: | Contribution of axillary lymph node dissection (ALND) is questioned for positive sentinel node (SN), micro-metastasis and isolated tumor cells but also for macro-metastasis. The aim of this work is to precise why a prospective randomized trial is necessary and the design of this trial. Why? For positive SN, the scientific level evidence appears insufficient for validation of ALND omission as a new standard. Rational is presented with non-sentinel node involved rate and number of NSL involved at complementary ALND, axillary recurrence rate, disease free survival rate and adjuvant treatment decision impact. How? The proposed Sentinelle Envahi et Randomisation du Curage (SERC) trial will randomly assign to observation only or complementary ALND with positive SN. The aim is to demonstrate the non-inferiority of ALND omission versus ALND. |
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| Keywords: | ganglion sentinelle cancer du sein curage axillaire essai randomisé sentinel node breast cancer axillary lymph node dissection randomised trial |
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