To assess the cosmetic effect of preoperative versus postoperative partial breast irradiation (prePBI vs postPBI)
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cosmetic outcome at 3 years
Secondary outcome
* Fibrosis/induration
* Breast pain
* Local relapse free survival
* Quality of life
* Disease free survival
* Distant metastases free survival
* Overall survival
Background summary
Most of the local recurrences (LR) found after breast-conserving therapy are
within or close to the tumor bed. (Elkhuizen 1998, Cajucom 1993 Osborne 1992)
This pattern of recurrence was confirmed by studies of breast conserving
surgery without adjuvant irradiation (Veronesi 1990) and by the update of the
NSABP B-06 trial. (Fisher 2002) In the EORTC boost trial, however, 29% of all
LR were found outside the area of the original tumor. (Bartelink 2007) Still, a
recent review of BCT trials showed that the site of local recurrences after BCT
was mostly in the tumor bed, with less than 10% of LR elsewhere in the breast.
(Sanders 2007)
This led to the concept of partial breast irradiation. With accelerated partial
breast irradiation (APBI), a limited volume of breast tissue is irradiated,
allowing for a higher dose per fraction compared to whole breast irradiation
(WBI), which is favorable considering the low */* ratio, and thus higher
sensitivity to high dose per fraction.
Study objective
To assess the cosmetic effect of preoperative versus postoperative partial
breast irradiation (prePBI vs postPBI)
Study design
Randomized phase III study
Intervention
Preoperative versus postoperative partial accelerated breast irradiation
Study burden and risks
In the previous PAPBI-1 clinical studiy it's proven there's no slight increased
risk of postoperative complications). When a postoperative hemorrhage occurs a
small operation will be done.
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Listed location countries
Age
Inclusion criteria
* Female patients * 51 years
* cT1-2 (* 3 cm)
* cN0
* Grade I or grade II (biopsy)
* Histologically proven invasive ductal adenocarcinoma
* Unifocal lesions on mammogram and MRI (small satellite lesions adjacent to
the tumor are accepted as long as it is suitable for local excision to be
determined by the participating centre)
* WHO performance * 2
* Life expectancy * 5 years
* Written informed consent
Exclusion criteria
* Distant metastases
* Lobular invasive carcinomas
* Pure DCIS without invasive tumor
* Grade III in biopsy
* Triple negative tumors
* HER2neu positive tumors
* Lymphvascular invasion in biopsy
* cN1-3
* pN+ (Micro- or macrometastases
* Multicentric / multifocal disease on mammogram or MRI
* Diffuse calcifications on mammogram (Birads 3, 4 or 5)
* Prior treatment for the protocol tumor (no surgery, no neoadjuvant
chemotherapy or neoadjuvant hormonal therapy, no previous radiotherapy)
* Previous contralateral breast cancer:
* Other neoplasms in the last 5 years with the exception of:
- Basal cell carcinoma of the skin
- Adequately treated carcinoma in situ of the cervix
* Planned oncoplastic resection with tissue displacement
* No social security affiliation/health insurance
* Participation in another clinical trial that interferes with the locoregional
treatment of this protocol
* It is expected that dosimetric constraints cannot be met, ie, lung/heart
constraints (see 6.1.5), or if the ratio PTV/ ipsilateral breast >30%
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02913729 |
| CCMO | NL53862.031.15 |