Breast cancer
Conditions
Interventions
Radiation therapy (38.5Gy /10fr /2 weeks) to the tumor bed region after breast-conserving surgery
Sponsors
Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine, Kyoto University
Mitsubishi heavy industries, Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients must fulfill all of the following conditions 1) clinical stage 0, I, II excluding T3 breast cancer with 3 cm or less histological tumor diameter. 2) Histologically confirmed ductal carcinoma in situ (DCIS), invasive ductal carcinoma, or specific type of carcinoma. 3) No tumor cells within 5 mm from the surgical margin in the histological specimens. 4) Single primary tumor. 5) Aged 40 years old or more. 6) No prior chemotherapy or hormonal therapy. 7) Breast-conserving surgery with lumpectomy or segmental mastectomy. Re-excision is permitted if clips are inserted in the final resection margin. 8) Inserted surgical clips in tumor resection margin. 9) Axillary lymph node dissection with level I or II, or histologically negative sentinel lymph nodes. allowance for no axillary dissection in DCIS 10) Three or less positive axillary lymph nodes including sentinel lymph nodes. 11) No prior radiation therapy against the thoracic. 12) Performance status of 0 or 1. 13) Written informed consent. 14) Asian woman with enough fluency in Japanese.
Exclusion criteria
Exclusion criteria: 1) Simultaneous or metachronous (within 5 years) double cancers. 2) Metachronous or simultaneous bilateral breast cancers 3) Infection with systemic therapy indicated. 4) Body temperature of 38 or more degrees Celsius. 5) Psychosis. 6) Uncontrollable diabetes mellitus or administration of insulin. 7) Scleroderma, systemic lupus erythematosus, dermatomyositis, or polymyositis. 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) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema. 12) Women during pregnancy, possible pregnancy or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| proportion of grade 3 or higher acute or late adverse events within 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| ipsilateral breast recurrence-free survival, proportion of protocol treatment completion, proportion of deterioration of breast cosmetic outcomes, disease-free survival, overall survival | — |
Countries
Japan
Contacts
Public ContactMichio Yoshimura
Graduate school of Medicine, Kyoto University Department of Radiation Oncology and Image-applied Therapy
Outcome results
None listed