Breast cancer
Conditions
Interventions
Proton beam therapy 62.4 GyE/26 fractions
Sponsors
Medipolis Proton Therapy and Research Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) UICC-TNM classification stage I (equal or less than 1.5 cm in diameter) breast cancer. 2) Mammographicaly visible tumor without calcification. 3) Pathologically invasive ductal carcinoma. 4) No massive lymphovascular invasion. 5) Estrogen receptor positive, favor of HER2 negative. 6) Age 40-70 years old. 7) Hight </= 175 cm, body weight </= 70 kg. 8) Favor of distance to skin or rib >/= 1 cm. 9) Negative lymph node metastasis by sentinel lymph node sampling. 10) No distant metastasis. 11) Performance status 0-1. 12) Written informed consent. 13) Phase I is clinical trial. 14) Phase II is cost burden. 15) Salvage surgery will be required if recurrence is observed.
Exclusion criteria
Exclusion criteria: 1) History of previous radiotherapy to the breast. 2) History of previous surgery/chemotherapy to the breast. 3) DCIS/LCIS 4) Massive intra-ductal spread. 5) Having infectious disease. 6) Having collagen disease or infectios skin disease. 7) Diabetes. 8) Pregnancy. 9) Other malignant disease. 10) Medically, psycholgicaliy or other reason who are not suitable for candidate by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events of normal tissue | — |
Secondary
| Measure | Time frame |
|---|---|
| location of local recurrence, duration of extra-breast recurrence, survival duration, cosmesis | — |
Countries
Japan
Contacts
Public ContactTakeshi Arimura
Medipolis Proton Therapy and Research Center Proton Radiation Oncology Division
Outcome results
None listed