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Nauwkeurigheid van partiele borstbestraling met het Cyberknife


- candidate number28413
- NTR NumberNTR6988
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jan-2018
- Secondary IDs64643 ABR
- Public TitleNauwkeurigheid van partiele borstbestraling met het Cyberknife
- Scientific TitleGeometric accuracy of accelerated partial breast irradiation on the Cyberknife using standard surgical clips as a fiducial marker
- ACRONYMCK-APBI
- hypothesisThe value for the optimal PTV margin for Accelerated Partial Breast Irradiation (APBI) on the Cyberknife is unknown. We plan to assess this value and compare the use of implanted gold markers, surgical clips and superficial gold markers as fiducials to track the target during radiotherapy delivery
- Healt Condition(s) or Problem(s) studiedMamma carcinoma, Breast cancer
- Inclusion criteria- Female
- Age > or = 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 > or = 2mm for DCIS
- ER positive
- pN0 confirmed by sentinel node biopsy or axillary lymph node dissection
- At least 3 surgical clips in the tumor bed, being large titanium 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-okt-2018
- planned closingdate1-okt-2019
- Target number of participants52
- InterventionsCT scan before each fraction of partial breast irradiation using the Cyberknife stereotactic radiotherapy system
- Primary outcomegeometric uncertainty of Cyberknife APBI and required PTV margin
- Secondary outcome- Proportion of patients where the surgical clips and superficial gold markers can successfully be used as fiducials
- Dosimetric gain of PTV margin reduction
- Acute toxicity
- TimepointsFor toxicity: 3 and 6 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. N. Hoekstra
- CONTACT for SCIENTIFIC QUERIESDrs. N. Hoekstra
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- Publications
- Brief summaryAccelerated partial breast irradiation (APBI) has become an accepted alternative to whole breast irradiation after breast conserving surgery for low-risk early-stage breast cancer patients. There are several techniques available for the delivery of APBI. The Cyberknife (CK) offers several advantages: it is non-invasive, can achieve a highly conformal dose distribution, and can track the target real-time during irradiation. The aim of this study is to determine the minimal safety margin required for CK-APBI to account for geometric uncertainties. In addition to determine this minimal value the study will compare the use of standard surgical clips, implanted gold markers and superficial gold markers as fiducials to track the target motion during radiotherapy delivery.
- Main changes (audit trail)
- RECORD8-jan-2018 - 5-feb-2018


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