breast cancer after breast-conserving surgery
Conditions
Interventions
Hypofractionated radiation therapy (42.56 Gy/ 16 fr/ 22 days) for whole breast. For patients with close margin, boost irradiation (10.64 Gy/ 4 fr/ 4 days) was added.
Sponsors
Japan Clinical Oncology Group(JCOG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Preoperative status fulfills all of the following conditions: i) single primary tumor, ii) tumor size 3 cm or less, iii) no distant metastasis, iv) no prior chemotherapy or hormonal therapy. 2) Intra- and Postoperative status fulfills all of the following conditions: i) breast-conserving surgery with lumpectomy or segmental mastectomy (endscopic surgery is excluded), ii) axillary lymph node dissection with level I or II, or histologically negative sentinel lymph nodes, iii) no simultaneous breast reconstruction, v) no ongoing treatments for postoperative complications. 3) Pathological findings fulfills all of the following conditions: i) invasive carcinoma, ii) three or less positive axillary lymph nodes, or histologically negative sentinel lymph nodes, iii) no tumor exposure to excision margin. 4) Adjuvant chemotherapy with anthracyclines or taxanes (only in case with high-risk factors). 5) Within 70 days from surgery in case without adjuvant chemotherapy, and within 28 days from the latest chemotherapy in case with adjuvant chemotherapy. 6) Asian woman with enough fluency in Japanese. 7) Aged 20 to 75 years old. 8) Performance status of 0 or 1. 9) No prior radiation therapy against the thoracic. 10) Sufficient organ functions. 11) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Simultaneous or metachronous (within 5 years) double cancers. 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) Scleroderma, systemic lupus erythematosus, dermatomyositis, or polymyositis. 9) Systemic steroids medication. 10) immunosuppressant for active collagen disease. 11) History of severe heart disease, heart failure, myocardial infarction within 6 months or attack of angina pectoris within 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of grade 2 or more late adverse reactions at 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, disease-free survival, ipsilateral breast recurrence-free survival, proportion of treatment completion in specific term, acute adverse events, proportion of deterioration of breast cosmetic outcomes, proportion of grade 2 or more late adverse reactions at 5 years | — |
Countries
Japan
Contacts
Public ContactMiwako Nozaki
JCOG0906 Coordinating Office Department of Radiology, Dokkyo Medical University Koshigaya Hospital
Outcome results
None listed