breast cancer breast carcinoma
Conditions
Interventions
RADIOTHERAPY:
•Trial arm 38.5 Gy total in 10 fractions (3.85 Gy per fraction), twice a day
with an interval of at least 6 hours between the two fractions, for five
consecutive working days.
• Cont
Sponsors
Modena University Hospital
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Females with Histologically confirmed invasive breast cancer pT 1-2 (= 2 mm) at first intervention or after subsequent widening - Radiological examination of the surgical specimen to assess the excision of the hidden lesions and/or the microcalcifications if present in the mammography carried out before surgery - Positioning of 3-6 metallic clips, or in any case of an appropriate number to delineate the area of surgical exeresis (tumor bed) - At least two weeks must have elapsed from the end of the chemotherapy if this is administered before the radiotherapy. In patients who do not receive chemotherapy, radiotherapy should start =49 - performance status 0-2 - life expectancy at least 5 years - written informed consent - Non-hormonal contraception in patients of childbearing age - Patients technically eligible for radiotherapy
Exclusion criteria
Exclusion criteria: •In situ carcinoma (CLIS and DCIS ) •Non-epithelial breast neoplasms (sarcoma, lymphoma etc.) •Micro/macrometastases in > 3 axillary lymph nodes; micro/macrometastases in the internal mammary and/or supraclavicular or subclavicular lymph nodes •Multicentric carcinomas (lesions in different quadrants of the breast or in the same quadrant but separated by at least 4 cm) or clinically or radiologically suspected lesions in the ipsilateral breast, unless their tumoral nature was excluded through biopsy or fine needle sample. •Palpable radiologically suspected ipsilateral or contralateral axillary, supraclavicular or infraclavicular, internal mammary nodes ( unless their tumoral nature was excluded through biopsy or fine needle sample) •Treatments for previous contralateral or ipsilateral breast cancers •Paget's disease of the nipple •Cutaneous involvement, independently of the tumor diameter •Distant metastases •Previous radiotherapy on the thoracic region •Previous neoadjuvant chemotherapy •Collagen diseases (systemic erythematosus lupus, scleroderma, dermatomiositis) •Other pathological conditions that limit life expectancy to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| survival free of local ipsilateral recurrence as prime event | — |
Secondary
| Measure | Time frame |
|---|---|
| global survival, locoregional recurrence-free, distant recurrence-free, acute and late toxicity (RTOG) and cosmetic result | — |
Countries
Netherlands
Outcome results
None listed