Breast Cancer
Conditions
Interventions
Ultra-hypofractionated whole breast adjuvant radiotherapy is given over 5 days (26 Gy in 5 fractions)
Sponsors
Kobe City Medical Center General Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. No distant metastasis confirmed via all exam before surgery 2. After breast-conserving surgery 3. Pathological findings fulfill all of the following conditions: i. invasive carcinoma or ductal carcinoma in situ ii. pathological stage review is indicated in pTis-3pN0-1 iii. no tumor exposure to excision margin 4. Within 70 days from surgery in case without adjuvant chemotherapy, and within 42 days from the latest chemotherapy in case with adjuvant chemotherapy 5. Asian woman with enough fluency in Japanese 6. >=40 years of age 7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 8. No prior radiation therapy against the thoracic 9. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Prior malignancies; except another malignancy and disease-free for > 5 years, or completely resected or successfully treated in situ carcinoma. 2. Infection with systemic therapy indicated 3. Body temperature of 38 or more degrees Celsius 4. Women during pregnancy, possible pregnancy or breast-feeding 5. Psychosis 6. Uncontrollable diabetes mellitus or administration of insulin 7. Interstitial pneumonia, pulmonary fibrosis, or severe emphysema. 8. Systemic steroids medication. 9. Immunosuppressant for active collagen disease. 10. History of severe heart disease, heart failure, myocardial infarction within 6 months or attack of angina pectoris within 6 months. 11. The patient inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of late adverse events within 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Progression-free survival, Ipsilateral breast tumour recurrence free survival, Ipsilateral breast tumour recurrence free rates, Incidence rate of acute adverse events within 3 months, Incidence rate of late adverse events within 5 years. | — |
Countries
Japan
Contacts
Public ContactTakamasa Mitsuyoshi
Kobe City Medical Center General Hospital Department of Radiation Oncology
Outcome results
None listed