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Property:Specifications on cancer therapies

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B
Continuous infusion of 2400 mg/m<sup>2</sup> of 5-fluorouracil (5-FU) over 46 to 48 hours, a bolus of 400 mg/m<sup>2</sup> of 5-FU, 400 mg/m<sup>2</sup> of leucovorin, and 85 mg/m<sup>2</sup> of oxaliplatin (mFOLFOX6) plus 5 mg/kg of bevacizumab administered intravenously every 14 days per institutional standard of care (1 cycle=14 days), bevacizumab was allowed to be omitted during the first cycle and started with cycle 2 at the investigator’s discretion  +
C
Types of radiotherapy per arm: - intervention: 9x radiotherapy, 16x concurrent chemoradiotherapy - placebo: 6x radiotherapy, 14x concurrent chemoradiotherapy N for adjuvant/definitive setting per arm: - intervention: 15/10 - placebo:9/11  +
Minimum of 6 months since completion of breast surgery, adjuvant chemotherapy (including trastuzumab), and radiation therapy Breast cancer treatments: n(%) Chemotherapy: Poly E arm 29(97); Placebo arm 10(100) Trastuzumab: Poly E arm 5(17); Placebo arm 2(20) Radiation therapy: Poly E arm 23(77); Placebo arm 8(80)  +
The protocol was amended during the course of the study, and patients receiving chemotherapy or radiation therapy were allowed under the modified protocol.  +
Radiotherapy only: intervention arm = 13; placebo arm = 10 Radiotherapy postoperative: intervention arm = 7; placebo arm = 2 Radiochemotherapy: intervention arm = 7; placebo arm = 15 Radiochemotherapy postoperative: intervention arm = 1, placebo arm = 1  +
D
All patients received 50-60 Gy of external beam radiation in 20-30 fractions over a period of 5 weeks, followed by intra-cavitary brachytherapy at a dose of 20–30 Gy using a BARC applicator.  +
Radiotherapy consisted of 30 daily sessions lasting six weeks (total dose = 5,040 cGys in the supraclavicular fossa and lymphatic drainages and reaching 7,040 cGys in the tumor). Platinum-based chemotherapy consisted of three cycles of cisplatin (100 mg/m2) every 21 days during the chemoradiotherapy.  +