Breast Neoplasms, Toxicity
Conditions
Keywords
Breast cancer, Intra Operative Radiation Therapy, Toxicity
Brief summary
Aim of the study is to evaluate toxicity in breast cancer patients treated with two different doses of Intra Operative Radiotherapy
Interventions
RADIATION21 Gy radiation
21 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)
RADIATION18 Gy radiation
18 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)
Sponsors
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Non lobular epithelial breast carcinoma, excised with standard quadrantectomy * Age ≥ 45 and \< 85 * Tumor major diameter ≤ 2.5 cm * Negative surgical margins (≥ 5 mm) * Willingness to undergo follow up examinations * Willingness to undergo imaging examinations (MRI, mammograms, ultrasonography) * Signed informed consent
Exclusion criteria
* Ductal carcinoma in situ or lobular carcinoma * Extensive intraductal component (greater than 25%) or intraductal carcinoma with microinvasion * Serious concomitant disease or any disorder or condition (such as psychiatric or addictive disorders) that, in the opinion of the investigator, would preclude the patient from meeting the study requirements * Pregnancy or lactation at the time of enrolment proposal (if necessary, during the trial patients must use effective contraceptive device) * Collagen vascular disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early toxicity | 6 months | Assessment of early toxicity using modified RTOG scale |
| Late toxicity | 5 years | Assessment of late toxicity using modified LENT scale |
| Cosmetic outcome | 5 years | Assessment of cosmetic outcome according to semi-objective criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Relapse Free Survival (LRFS) | 10 years | 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 |
| Disease Free Survival (DFS) | 10 years | 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 |
Countries
Italy
Outcome results
None listed