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Brief Title: Super Hypofractionated Irradiation For Whole Breast Treatment
Official Title: Super Hypofractionated Irradiation For Whole Breast Treatment: A Prospective, Single-arm Trial
Study ID: NCT04926766
Brief Summary: The purpose of this trial is to investigate the safety and efficacy of super hypofractionated whole breast irradiation (SHF-WBI) in breast cancer patients treated with breast conserving surgery. Eligible breast cancer patients will be followed for at least 5 years to evaluate the acute and late radiation-induced toxicities, locoregional recurrence, distant metastasis, death, contralateral breast cancer and quality of life.
Detailed Description: Eligible breast cancer patients will receive SHF-WBI of 5.2 Gy in 5 fractions to ipsilateral whole breast within one week and a sequential tumor bed boost of 5.2 Gy in 2 fractions at the discretion of the radiation oncologist. All patients are treated with intensity modulated radiation therapy (IMRT) technique. The primary endpoint is ≥2 grade any acute radiation induced toxicity event. Patients will be followed for at least 5 years to evaluate the acute and late radiation-induced toxicity, locoregional recurrence, distant metastasis, death and quality of life. Calculation of the required number of cases based on an alpha of 0.05 and a power of 80% with a maximal tolerable toxicity difference of 10% during and within 6 months after SHF-WBI comparing to hypofractionated whole breast irradiation(40-42.5Gy/15-16Fx) and lost rate of follow up of 10%. In total 217 patients are needed to be recruited.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China
Name: Jiayi Chen, PhD
Affiliation: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medcine
Role: STUDY_CHAIR
Name: Lu Cao, PhD
Affiliation: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medcine
Role: PRINCIPAL_INVESTIGATOR