To compare Clinical Target Volumes after RFIB (CTV-RFIB) and after BCS (CTV-POC).
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
CTV-RFIB and CTV-POC.
Secondary outcome
Not applicable.
Background summary
In DCIS and early-stage breast cancer patients, breast-conserving therapy is
today*s standard of care. Breast-conserving therapy consists of
breast-conserving surgery (BCS) and radiotherapy (RT). Besides tumor excision
by the surgeon, a margin of breast tissue surrounding the tumor has to be
treated by the surgeon and radiation oncologist due to the potential presence
of additional microscopic tumor foci. Therefore, post-operatively, a
radiotherapy (RT) planning CT scan is performed, and the excisional area,
called the post-operative complex (POC), has to be identified. This POC has to
be irradiated with a 1.5 cm margin, minus the minimal tumor free margin (as
described in the pathology report). This is called the Clinical Target Volume
(CTV).
Recently, 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. The biopsy specimens are small, but the
excision cavity walls are not approximated as in BCS. Large target volumes are
associated with worse cosmetic result and a higher dose in surrounding organs
which can result in an increased risk of lung and cardiovascular disease.
Study objective
To compare Clinical Target Volumes after RFIB (CTV-RFIB) and after BCS
(CTV-POC).
Study design
Prospective cohort study, using CT imaging
Study burden and risks
Patients will undergo one additional CT scan preoperatively. The effective dose
equivalent of this CT scan is approximately 0.10 Sv. Considering the radiation
dose delivered to the ipsilateral breast (42,56 / 50 Gy) and its scattered dose
to adjacent structures, the risk of one additional CT scan will be marginal.
This CT scan ideally will be scheduled in combination with another in-house
pre-operative appointment. When an additional visit to the hospital is
required, patients will receive reimbursement of travelling expenses. For the
patients included in the study there is no individual benefit.
Heidelberglaan 100
3584CX
NL
Heidelberglaan 100
3584CX
NL
Listed location countries
Age
Inclusion criteria
- Female gender;
- Age >=18
- cTis-T1N0 breast cancer;
- RFIB procedure showing microscopically tumor free resection margins
- Scheduled for breast-conserving therapy (BCS + WBRT);
- Before breast-conserving surgery;
- Written informed consent.
Exclusion criteria
- Legal incapability;
- Insufficient command of the Dutch language;
- Inability to maintain the standard supine RT treatment position for 30 minutes;
- Treated with neo-adjuvant systemic therapy;
- Treated with a modified radical mastectomy or breast amputation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL38117.041.11 |
| OMON | NL-OMON24565 |