Breast cancer with low risk of recurrence:partial and accelerated radiation with three dimensional conformal radiotherapy (3DCRT) vs standard radiotherapy after conserving surgery (phase III study) - IRMA

Modena University Hospital0 个研究点目标入组 420 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•- Females with Histologically confirmed invasive breast cancer pT 1-2 (< 3 cm in diameter) pN0-N1 M0 .
•- Unifocal disease (confirmed radiologically and histologically)
•- 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 (>= 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 > =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

•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 < 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
•Pregnancy and breast-feeding

发起方

Modena University Hospital