The purpose of this study is to evaluate the Giro-couch, an innovative patient support device for the application of prone RT for treatment of breast cancer. This study will assess the feasibility of a new positioning approach to facilitate the delivery of external beam, delivered to the lumpectomy cavity, (the boost dose, partial breast therapy).
Treatments are applied with the subject in the supine position, in \~50 Gy per treatment (\~2GY per fraction), over a period of five to six weeks. Energy in use is usually 6-15MV photons. Following the whole breast irradiation, a boost dose is given to the lumpectomy cavity, in order to further reduce the local recurrences in the immediate vicinity of the treated breast. The boost dose is usually applied with electrons, 6-18MEV. Sixteen Gy is the usual dose, 2 Gy/Fx, for 8 fractions.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Boost irradiation is applied to the ipsilateral breast in eight fractions of 2Gy/Fx
The Chaim Sheba Medical Center
Tel Litwinsky, Israel
Ease of use and Comfort scale 1-5
The endpoints will be assessed at the conclusion of the subject's first treatment on Treatment Day 1, and at the conclusion of the subject's treatment on Treatment Day 8. Thus the time frame for the Primary Outcome Measure for each subject is 1-8 days.
Time frame: Treatment Day 1 and Treatment Day 8
Dosimetric evaluation
A Dosimetric evaluation will be performed for each subject, each and every day of subjects's treatment.
Time frame: Treatment Day 1, Treatment Day 2, Treatment Day 3, Treatment Day 4, Treatment Day 5, Treatment Day 6, Treatment Day 7, Treatment Day 8
Localization time
The time required for target localization will be performed each and every day of each subject's treatment.
Time frame: Treatment Day 1, Treatment Day 2, Treatment Day 3, Treatment Day 4, Treatment Day 5, Treatment Day 6, Treatment Day 7, Treatment Day 8
Treatment time
The time required to apply the prescribed treatment (beam on to beam off).
Time frame: Treatment Day 1, Treatment Day 2, Treatment Day 3, Treatment Day 4, Treatment Day 5, Treatment Day 6, Treatment Day 7, Treatment Day 8
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