Clareo Health | Breast Cancer With Low Risk Of Local Recurrence: Partial and Accelerated Radiation With Three-Dimensional Conformal Radiotherapy (3DCRT) Vs. Standard Radiotherapy After Conserving Surgery (Phase III Study
Breast Cancer With Low Risk Of Local Recurrence: Partial and Accelerated Radiation With Three-Dimensional Conformal Radiotherapy (3DCRT) Vs. Standard Radiotherapy After Conserving Surgery (Phase III Study
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Regione Emilia-Romagna
Age
49–85
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed invasive breast cancer
pT 1-2 (\< 3 cm in diameter) pN0-N1 M0 according to TNM classification.
Unifocal disease (confirmed radiologically and histologically)
Eligible histotypes: all except for non-epithelial histotypes (lymphoma, sarcoma)
Hormonal receptor status: indifferent
Patients undergoing conservative breast surgery for neoplasms with a diameter \< 3 cm and with biopsy of the sentinel lymph node or first instance axillary dissection.
Breast resection margins histologically negative (³ 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 \< 12 weeks after surgery.
No chemotherapy must be carried out during or at least two weeks after completion of the radiotherapy
Treatment with tamoxifen or aromatase inhibitors is allowed at the same time
Age ³ 49
Gender: female
Menopause status: unspecified
Performance status: 0-2 according to ECOG
Life expectation: at least five years
INFORMED consent: yes
Non-hormonal contraception in patients of childbearing age
You may not be if
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
Other pathological conditions that limit life expectancy to \< 5 years
Psychiatric diseases or disorders of other nature that prevent signing of informed consent for the treatment
Other neoplasms in the last 5 years with the exception of skin tumors apart from melanoma and squamous intraepithelial lesions (SIL) of the uterine cervix
