Breast Cancer
Conditions
Interventions
Hypofractionated whole breast irradiation therapy (43.2Gy/18fr) with concurrent boost (50.4Gy/18fr) after breast conserving surgery
Sponsors
Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine, Kyoto University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients must fulfill all of the following conditions 1) clinical stage I, II 2) pathologically proven diagnosis of invasive ductal carcinoma, or specific type of carcinoma 3) positive resection margin or close resection margin within 5mm 4) Aged 20 years old or more 5) breast conserving surgery 6) inserted surgical clips in tumor resection margin or mark indicating the resection margin on the skin 7) whole breast irradiation without regional (supraclavicular or parasternal) nodal irradiation planned 8) no prior radiation therapy to thoracic 9) performance status (ECOG) of 0 or 1 10) written informed consent 11) oriental women with enough fluency in Japanese
Exclusion criteria
Exclusion criteria: 1) Prior invasive non-breast malignancy (except carcinoma in situ) unless disease free for a minimum of 5 years prior to study entry 2) Metachronous or simultaneous bilateral breast cancers 3) Acute infection requiring systemic therapy 4) Body temperature 38 degrees Celsius or more at registration 5) Psychiatric or other condition that would prevent the patient from receiving the protocol therapy 6) Uncontrollable diabetes mellitus or administration of insulin 7) Active or prior history of scleroderma, systemic lupus erythematosus, dermatomyositis, or polymyositis 8) Systemic steroids or immunosuppressant medication 9) Severe heart failure or angina attack or myocardial infarction within the last 6 months 10) Interstitial pneumonia, pulmonary fibrosis, or severe chronic obstructive pulmonary disease 11) Pregnancy, pregnancy potential, after giving birth within 28 days, or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| proportion of acute adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| proportion of late adverse events, proportion of deterioration of breast cosmetic outcomes | — |
Countries
Japan
Contacts
Public ContactMichio Yoshimura
Graduate school of Medicine, Kyoto University Department of Radiation Oncology and Image-applied Therapy
Outcome results
None listed