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Geometric accuracy of accelerated partial breast irradiation on the Cyberknife using standard surgical clips as a fiducial marker

Completed
Conditions
breast cancer
breast carcinoma
10006291
10006295
Registration Number
NL-OMON48772
Lead Sponsor
Radiotherapie
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
51
Inclusion Criteria

- Female
- Age * 50 years
- Stage pTis, pT1 or pT2 (tumor size < 3 cm) breast cancer
- Invasive ductal, mucinous, tubular, medullary or colloid carcinoma or DCIS
- Treated with breast-conserving surgery
- Resection margins negative at ink for invasive cancer and by * 2mm for DCIS
- ER positive
- pN0 confirmed by sentinel node biopsy or axillary lymph node dissection. If the risk of regional metastasis is deemed so low that a sentinel node is not indicated (for example in DCIS), cN0 is sufficient and patients are eligible for trial participation without sentinel node biopsy.
- At least 3 surgical clips in the tumor bed, being large titanium (1 cm) or tantalum type

Exclusion Criteria

- Lympho-vascular infiltration
- Extensive intraductal component
- Multifocal or multicentric disease
- Invasive lobular carcinoma
- Distant metastasis
- Neoadjuvant chemotherapy
- Prior irradiation to the chest
- Inability to read Dutch

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main study endpoint is to report the geometric uncertainty of CK-APBI in<br /><br>order to calculate the required PTV margin.</p><br>
Secondary Outcome Measures
NameTimeMethod
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