NL-OMON45437
Recruiting
Phase 2
Partial Breast Radiotherapy in Low-risk Breast cancer group using a stereotactic MR-guided adaptive approach; a phase II study - PARLOB
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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.
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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