Aim of the study is to evaluate toxicity in breast cancer patients treated with two different doses of Intra Operative Radiotherapy
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
21 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)
18 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)
IRCCS AOU San Martino- IST
Genoa, Italy
Early toxicity
Assessment of early toxicity using modified RTOG scale
Time frame: 6 months
Late toxicity
Assessment of late toxicity using modified LENT scale
Time frame: 5 years
Cosmetic outcome
Assessment of cosmetic outcome according to semi-objective criteria
Time frame: 5 years
Local Relapse Free Survival (LRFS)
Local recurrence rate will be continuously monitored in order to stop the trial in case results will be consistently worse than expected according to literature data
Time frame: 10 years
Disease Free Survival (DFS)
Disease Free Survival will be continuously monitored in order to stop the trial in case results will be consistently worse than expected according to literature data
Time frame: 10 years
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