About this trial
This is a prospective, registry study that will enroll all women with early stage breast cancer who will be treated with intraoperative radiotherapy (IORT) during breast-conserving surgery. The purpose of this study is to further validate the long-term effectiveness and safety of this treatment method. We aim to assess short and long-term patient outcomes associated with IORT, including perioperative complications, local and distance disease recurrences, as well as disease-free survival and overall survival.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical stage Tis, T1, or T2(≤ 3cm), N0, M0 (AJCC Classification)
Unifocal Disease
Candidate for breast-conserving surgery
Recommended treatment by multidisciplinary team
Disqualifiers
Clinical stage T3-4, N1-3, M1
Multifocal disease
Trial population
Any individual aged ≥ 18 years with early stage breast cancer who is determined to be suitable candidates for breast-conserving surgery and IORT by a multidisciplinary team.
Trial design
Cohort
Prospective
Treatments tested in this trial
Intraoperative Radiation Therapy (IORT)
RadiationIORT involving 50kV Xrays to a dose of 20 Gy during breast-conserving surgery
Treatment groups
Trial outcomes
Primary outcomes
Disease Recurrence
Presence of recurrent tumor in ipsilateral breast or distant site
Secondary outcomes
Disease specific survival
survival
Overall Survival
survival
Sponsors and contacts
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