Modena University Hospital
Ph. Poortmans-L.J. Boersma
A.E. van Leeuwen-Stok
Clinical Trials Office, University of Modena Tel. +39 059 422 3865 roberto.vicini@unimore.it
Quality assurance RT via dummy runs
IKNL
Funding KWF-CKS
Randomization: Experimental arm: 38.5 Gy total in 10 fractions (3.85 Gy per fraction), twice a day with an interval of at least 6 hours between the two fractions, for five consecutive working days. Control arm: 45 Gy/18 fractions, or 50 Gy/25 fractions, or 50,4 Gy/28 fractions, or iso-effective fraction schemes, once a day for 5 days a week. A 10 – 16 Gy boost is allowed in centers where it is part of the standard treatment.
To evaluate whether partial hypofractionated and accelerated irradiation of the sole surgical cavity, in patients suffering from breast cancer with low risk of local recurrence and undergoing conservative surgery, is not inferior to postoperative irradiation with conventional fractionation of the entire breast as regards local control, measured in terms of incidence of ipsilateral recurrences as first event.
Primary endpoint:
Secondary endpoints:
Female, pT 1-2 (< 3 cm in diameter) pN0-N1 M0 Unifocal Histologically negative resection margins (≥ 2 mm) at first intervention or after subsequent widening Undergoing conservative breast surgery for invasive breast cancer
