NL-OMON26191
Recruiting
Not 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 enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Amsterdam UMC, location VUmc
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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
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
Outcomes
Primary Outcomes
Not specified
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