Spots Global Cancer Trial Database for Omitting Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy
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Trial Identification
Brief Title: Omitting Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy
Official Title: The Value of Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy. A Dutch Randomized Controlled Multicentre Trial.
Study ID: NCT02112682
Conditions
Interventions
Study Description
Brief Summary: STUDY AIM To decrease the number of breast cancer patients receiving overtreatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life. PRIMARY OBJECTIVE To determine whether omitting completion axillary treatment is not inferior to the current axillary treatment regimen in sentinel node positive breast cancer patients undergoing a mastectomy, in terms of regional recurrence rate. HYPOTHESIS Completion axillary treatment can be safely omitted in sentinel node positive breast cancer patients undergoing a mastectomy. This will lead to a decreased axillary morbidity rate and to an increased quality of life, with non-inferior regional control, distant-disease free- and overall survival rates.
Detailed Description:
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
Meander Medisch Centrum, Amersfoort, , Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, , Netherlands
Gelre Ziekenhuizen, Apeldoorn, , Netherlands
Rijnstate, Arnhem, , Netherlands
Amphia ziekenhuis, Breda, , Netherlands
Reinier de Graaf, Delft, , Netherlands
Jeroen Bosch ziekenhuis, Den Bosch, , Netherlands
Bronovo / Medisch Centrum Haaglanden, Den Haag, , Netherlands
Haga Ziekenhuis, Den Haag, , Netherlands
Deventer Ziekenhuis, Deventer, , Netherlands
Catharina Ziekenhuis Eindhoven, Eindhoven, , Netherlands
Medisch Spectrum Twente, Enschede, , Netherlands
Groene Hart Ziekenhuis, Gouda, , Netherlands
Martini Ziekenhuis, Groningen, , Netherlands
UMC Groningen, Groningen, , Netherlands
Zuyderland Medisch Centrum, Heerlen, , Netherlands
Tergooi, Hilversum, , Netherlands
Alrijne ziekenhuis, Leiden, , Netherlands
St. Antonius Ziekenhuis, Nieuwegein, , Netherlands
Canisius-Wilhelmina Ziekenhuis, Nijmegen, , Netherlands
Radboud university medical center, Nijmegen, , Netherlands
Laurentius Ziekenhuis, Roermond, , Netherlands
Zuyderland Medisch Centrum, Sittard, , Netherlands
Antonius Ziekenhuis, Sneek, , Netherlands
Rivierenland, Tiel, , Netherlands
St. Elisabeth Ziekenhuis, Tilburg, , Netherlands
Diakonessenhuis Utrecht, Utrecht, , Netherlands
Maxima Medisch Centrum, Veldhoven, , 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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