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Post-INTACT and post-operative clinical target volumes.


- candidate number10706
- NTR NumberNTR3199
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-dec-2011
- Secondary IDsNL38117.041.11 CCMO
- Public TitlePost-INTACT and post-operative clinical target volumes.
- Scientific TitleComparison of post-INTACT and post-operative clinical target volumes in breast-conserving therapy: A prospective cohort study.
- ACRONYMRT-INTACT
- hypothesisRadical INCTACT-biopsy instead of breast-conserving surgery would lead to smaller radiotherapy target volumes.
- Healt Condition(s) or Problem(s) studiedRadiotherapy, Target volume delineation
- Inclusion criteria1. Female gender;
2. Age 18;
3. cTis-T1N0 breast cancer;
4. RFIB procedure showing microscopically tumor free resection margins;
5. Scheduled for breast-conserving therapy (BCS + WBRT);
6. Before breast-conserving surgery;
7. Written informed consent.
- Exclusion criteria1. Legal incapability;
2. Insufficient command of the Dutch language;
3. Inability to maintain the standard supine RT treatment position for 30 minutes;
4. Treated with neo-adjuvant systemic therapy;
5. Treated with a modified radical mastectomy or breast amputation.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-dec-2011
- planned closingdate1-dec-2013
- Target number of participants30
- InterventionsPlanning CT-scan after radical INTACT biopsy.
- Primary outcomeClinical target volumes after INTACT biopsy and after breast-conserving surgery.
- Secondary outcomeN/A
- TimepointsPost-INTACT target volume delineation vs. post-BSC delineation.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. M.D. Hartogh, den
- CONTACT for SCIENTIFIC QUERIESDrs. M.D. Hartogh, den
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryRecently, a new breast-biopsy procedure called Radiofrequency-assisted Intact Specimen Biopsy (RFIB) has been introduced in the UMC Utrecht. Besides a higher diagnostic accuracy, this method has shown the potential of radical excision of small breast tumors. In the future, RFIB might be used as a minimally invasive therapeutic procedure in selected breast cancer patients. A radical RFIB procedure always has to be followed by RT. Therefore, we will observe the change in RT target volumes after RFIB.
- Main changes (audit trail)
- RECORD16-dec-2011 - 26-mrt-2014


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