Spots Global Cancer Trial Database for Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy
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Trial Identification
Brief Title: Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy
Official Title: Clinically Node Negative Breast Cancer Patients Undergoing Breast Conserving Therapy: Sentinel Lymph Node Procedure Versus Follow-Up.
Study ID: NCT02271828
Conditions
Interventions
Study Description
Brief Summary: STUDY AIM To decrease the number of breast cancer patients receiving over treatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life. PRIMARY OBJECTIVE To determine whether omitting the sentinel lymph node procedure is not inferior to the current axillary staging regimen in clinically node negative breast cancer patients undergoing breast conserving therapy, in terms of regional recurrence rate. HYPOTHESIS The sentinel lymph node procedure can be safely omitted in clinically node negative breast cancer patients undergoing breast conserving therapy. This will lead to a decreased axillary morbidity rate, with a non-inferior regional recurrence-, distant-disease free- and overall survival rates.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Maastricht University Medical Centre+, Maastricht, Limburg, Netherlands
Flevoziekenhuis, Almere, , Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, , Netherlands
Rijnstate, Arnhem, , Netherlands
Amphia ziekenhuis, Breda, , Netherlands
Jeroen Bosch ziekenhuis, Den Bosch, , Netherlands
Haga ziekenhuis, Den Haag, , Netherlands
Deventer ziekenhuis, Deventer, , Netherlands
Catharina ziekenhuis, Eindhoven, , Netherlands
Maxima Medisch Centrum, Eindhoven, , Netherlands
Groene Hart ziekenhuis, Gouda, , Netherlands
UMC Groningen, Groningen, , Netherlands
Spaarne Gasthuis, Haarlem, , Netherlands
Alrijne, Leiden, , Netherlands
St. Antonius ziekenhuis, Nieuwegein, , Netherlands
Canisius-Wilhelmina ziekenhuis, Nijmegen, , Netherlands
Radboud UMC, Nijmegen, , Netherlands
Laurentius ziekenhuis, Roermond, , Netherlands
Diakonessenhuis, Utrecht, , Netherlands
UMC Utrecht, Utrecht, , Netherlands
Zuwehofpoort ziekenhuis, Woerden, , Netherlands
Isala Klinieken, Zwolle, , Netherlands
Contact Details
Name: Marjolein L Smidt, MD, PhD
Affiliation: Maastricht University Medical Centre, Maastricht, the Netherlands
Role: PRINCIPAL_INVESTIGATOR
Name: Hans JW de Wilt, MD, PhD
Affiliation: Radboud University Medical Centre, Nijmegen, the Netherlands
Role: PRINCIPAL_INVESTIGATOR
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