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Clinical Trials/NL-OMON45437
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

Vrije Universiteit Medisch Centrum0 sites50 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational non invasive

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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