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PBI for Breast in Situ Carcinoma of Intermediate Low Risk As Local Adjuvant Treatment
Sponsor: Istituto Clinico Humanitas
Summary
Screening and advances in breast imaging led to a continuous increase of Ductal Carcinoma in situ (DCIS) diagnosis. Whole breast radiotherapy was reported to be effective in reducing the risk of local recurrence in all analyzed patients and tumor characteristics. In order to de-escalate treatment in low and intermediate DCIS, it is possible to investigate the role of partial breast irradiation (PBI). To date, data from available literature supports the hypothesis that PBI is a safe well tolerated therapy that appears to be equivalent to WBI in terms of efficacy and ultimate breast cosmesis.
Official title: Partial Radiotherapy for Breast in Situ Carcinoma of Intermediate Low Risk As Local Adjuvant Treatment
Key Details
Gender
FEMALE
Age Range
41 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2023-01-09
Completion Date
2029-12
Last Updated
2025-02-03
Healthy Volunteers
No
Conditions
Interventions
external beams radiotherapy
External beam radiation therapy uses high doses of radiation to destroy cancer cells and shrink tumors. A large machine aims radiation at the cancer. The allowed schedules for external beams radiotherapy are: * 40 Gy in 15 fractions; * 30 Gy in 5 fractions; * 40 Gy or 38.5 in 10 twice-daily fractions (each daily dose must be separated by at least 6 hours).
brachytherapy
Brachytherapy is a form of radiation therapy where a sealed radiation source is placed inside or next to the area requiring treatment. The schedule for brachytherapy are: * 32 Gy in 8 twice-daily fractions for HDR; * 30.3 Gy in 7 twice-daily fractions for HDR; * 50Gy 0.60-0.80 Gy/hour (1 pulse/hour, 24 hours/day) for PDR.
Locations (1)
IRCCS Istituto Clinico Humanitas
Rozzano, Milano, Italy