NL-OMON26191RecruitingNot Applicable
Partial Breast Radiotherapy in Low-risk Breast cancer group using a MR-guided adaptive approach; a phase II study
Amsterdam UMC, location VUmc0 sites50 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
Inclusion Criteria
- •Good candidates for partial breast irradiation according to the GEC-ESTRO recommendations are patients selected in the low-risk group. In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •-Age > 50 years
- •-WHO performance score 0-2
- •-Pathology proven breast cancer with following histology: invasive ductal carcinoma, mucinous, tubular, medullary, colloid cc, and associated LCIS
- •-Any histologic grade
- •-Any hormonal receptor status
- •-T-stage: Tumor size = 3cm (pT1-2)
- •-N-stage: No positive lymph nodes examined by sentinel lymph node biopsy or axillary lymph node dissection (at least 6 nodes pathologically examined)
- •-Radical resection of tumor with = 2mm surgical margin free of tumour
- •-All patients should be able to undergo MRI scans
- •-Ability to provide written informed consent.
- •-Ability to perform breath-hold for at least 17 seconds
Exclusion Criteria
- •According to the GEC-ESTRO recommendations, subject who meets any of the following criteria will be excluded from participation in this study:
- •-Breast cancer histology of invasive lobular carcinoma, ductal carcinoma in situ sec
- •-Breast cancer with a multicentric or multifocality character
- •-An extensive intraductal component in pathology examination
- •-Lympho-vascular invasion in the pathology examination
- •-Treatment with neoadjuvant chemotherapy before lumpectomy
- •-Breast conserving surgery with an oncoplastic breast surgery technique
- •-Re-excision of tumour in ipsilateral breast
- •-Open surgical wound or wound infection
- •-Previous irradiation in the ipsilateral breast
- •-Contra-indications for MRI
Investigators
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