This phase II study is to evaluate the safety of hypofractionated whole breast radiation (HFRT) with simultaneous tumor bed boost(SIB) in women with early breast cancer after breast-conserving surgery.
OBJECTIVES: Primary: To determine the toxicity with adjuvant hypofractionated whole breast radiation with simultaneous tumor bed boost (SIB) in women with early breast cancer after breast conserving surgery. Secondary: To determine the short term cosmetic and quality of life of the participants treated with this regimen. To determine the local control of the participants treated with this regimen. OUTLINE: Patients undergo adjuvant hypofractionated whole breast radiation with simultaneous tumor bed boost once daily a week for 3 weeks. Toxicity, quality of life and cosmetic result is assessed before radiation, at the end of the radiation, within 2, 4, 6 weeks after completion of radiotherapy, and then every 3 months for 1 ear. PROJECTED ACCRUAL: A total of 90 participants will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Radiation to the whole breast: 43.5 Gy in 15 fractions in 3 weeks. Simultaneous radiation to the surgical cavity: 49.5 Gy in 15 fractions in 3 weeks. Intensity modulated radiation treatment is used.
National Cancer Center/Cancer Hosptial, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
acute radiation induced dermatitis by CTCAE within 3 months
radiation induced skin toxicity, including rash, dry skin, ulceration etc., occurring immediately after radiation.
Time frame: 3 months
late radiation toxicity by CTCAE every 3 months to 1 years after 3 months of completion of radiation
any radiation induced toxicity occurring after the radiation
Time frame: 3 months to 1 year
breast cosmetic result as measured by Harvard scale of breast cosmesis (excellent, good, fair, poor) every 3 months for 1year
breast cosmetic evaluation after breast conserving surgery and radiation, using Harvard scale.
Time frame: every 3 months for 1year
quality of life as measured by Functional Assessment of Cancer Therapy-Breast Scale (FACT-B) every 3 months for 1 year
Functional Assessment of Cancer Therapy-Breast Scale (FACT-B) is used to evaluated the quality of life: all scale range: 0-144; sub-scale range: physical well being: 0-28; social well being: 0-28; emotional well being 0-24; functional well being 0-28; additional consideration: 0-36; the higher the better
Time frame: every 3 months for 1 year
quality of life as measured by Breast Cancer Treatment Outcome Scale(BCTOS) every 3 months for 1 year
Functional Assessment of Breast Cancer Treatment Outcome Scale(BCTOS) is used to evaluated the quality of life. the range of BCTOS is 22-88, the smaller the better
Time frame: every 3 months for 1 year
in-breast recurrence rate at 1 year of radiation completion
recurrence occurred in the treated breast.
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Time frame: 1 year