This is a prospective non randomized phase two trial evaluating the feasibility of a ten fraction accelerated hypofractionated radiotherapy schedule with simultaneous integrated boost risk adapted in patients undergoing breast conserving surgery for early breast cancer
Patients enrolled for the study, according to eligibility criteria, undergo breast conserving surgery followed by adjuvant 10-fraction whole breast irradiation with a risk adapted simultaneous-integrated boost dose at the level of the tumour bed according to clinical and pathological risk factors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 40 Gy
Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 43 Gy
Regina Elena Cancer Institute
Rome, Lazio, Italy
Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) scale
Incidence of grade 2-3 late toxicity in terms of skin toxicity
Time frame: From the end of treatment at 3 years
Incidence of local tumor relapse, distant metastasis and assessment of overall survival
Identification of local tumor relapse in the breast parenchyma within boost volume, breast parenchyma within volume receiving 34Gy; identification of distant metastasis and analysis of overall survival
Time frame: Time from the date of the diagnosis of primary breast cancer to the date of diagnosis of local relapse, distant metastasis or death from any cause, assessed up to 60 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.