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Sentinel Node And Recurrent Breast cancer


- candidate number3995
- NTR NumberNTR1450
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-sep-2008
- Secondary IDsM07-1792  NL 19199.060.07
- Public TitleSentinel Node And Recurrent Breast cancer
- Scientific TitleSentinel Node And Recurrent Breast cancer
- ACRONYMSNARB
- hypothesisDue to surgery and radiotherapy lymph drainage pathways in recurrent breast cancer could be altered. These aberrant drainage pathways could be detected with lymphatic mapping and sentinel node biopsy leading to a more thorough staging and possible change in treatment strategy.
- Healt Condition(s) or Problem(s) studiedMamma carcinoma, Relapse, Sentinel node biopsy
- Inclusion criteria1. Women above 18 years old with locally recurrent breast cancer after earlier BCT or modified radical mastectomy.
2. Operable cytological /histological confirmed locally recurrent breast cancer.
3. Having obtained an informed consent.
- Exclusion criteria1. Proven ipsi- or contralateral regional lymph node metastases (ultrasound and FNA).
2. Known to be allergic to “99mTc-colloidal albumin” or blue dye injection fluids.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-mrt-2008
- planned closingdate1-jan-2011
- Target number of participants150
- InterventionsLymfatic Mapping and sentinel lymph node biopsie.
- Primary outcome- Registration of technical feasibility of lymphatic mapping and sentinel node biopsy in patients with locally recurrent breast cancer.
- Registration of success rate of lymphatic mapping and SNB in patients with locally recurrent breast cancer.
- Registration of validity of lymphatic mapping and sentinel node biopsy in patients with locally recurrent breast cancer.
- Secondary outcome- Registration of lymphatic drainage pathways in patients with locally recurrent breast cancer.
- Registration of sentinel lymph node status in patients with locally recurrent breast cancer.
- Registration of possible influence of lymphatic mapping and SNB on therapeutic decisions in patients with locally recurrent breast cancer.
- Timepoints- Pre-operative inclusion
- Operation
- Post-operative registration: first post-operative consult
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. A. Maaskant-Braat
- CONTACT for SCIENTIFIC QUERIESDrs. A. Maaskant-Braat
- Sponsor/Initiator Catharina Hospital Eindhoven, Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
Catharina Hospital Eindhoven, Department of Surgery
- PublicationsN/A
- Brief summaryRationale:
Like in primary breast cancer, prognosis in recurrent breast cancer is correlated with regional lymph node status. Therefore, it seems sensible to perform lymphatic staging in case of an intact axillary lymph node basin, although this has not been described in guidelines yet. Due to surgery and radiotherapy lymph drainage pathways could be altered. These aberrant drainage pathways could be detected with lymphatic mapping and sentinel node biopsy leading to a more thorough staging and possible change in treatment strategy.

Objective:
To propose a regional staging protocol, lymphatic mapping and sentinel node biopsy, for patients with locally recurrent breast cancer in the absence of guidelines for regional staging procedures and to registrate data derived from this study.

Study design:
A prospective, multicenter, national registration study.

Study population:
At least 150 women above 18 years old with locally recurrent breast cancer after earlier BCT or modified radical mastectomy.

Main study parameters/endpoints:
Registration of technical feasibility and validity of lymphatic mapping and sentinel node biopsy in patients with locally recurrent breast cancer as well as registration of lymphatic drainage pathways and sentinel lymph node status. Furthermore, the influence of this staging procedure on therapeutic decisions will be evaluated.
- Main changes (audit trail)
- RECORD18-sep-2008 - 24-sep-2008


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