Investigators hypothesize that hypofractionated radiotherapy is equal effective and safe as conventional radiotherapy in breast cancer patients undergoing regional nodal irradiation.
Eligible breast cancer patients are randomized 1:1 into the following two groups:
1. Hypofractionated therapy: 40 Gy in 15 fractions of 2.67 Gy in breast or chest wall and nodal drainage with Concurrent boost 48.0 Gy / 3.2 Gy daily in tumor bed, in case of conservative surgery;
2. Standard fractionation: 50 Gy in 25 fractions in breast or chest wall and nodal drainage with sequential tumor bed boost with 10 Gy in 5 fractions in tumor bed in case of conservative surgery.
Patients will be followed for 6 months after radiotherapy to evaluate acute toxicity and quality of life.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Female;
Older than 18;
Breast cancer stage T1 - T3;
At least 1 lymph node positive;
Treated with mastectomy or conservative surgery;
Negative surgical margins;
No distant metastasis;
No supraclavicular or internal mammary nodes metastases;
Adjuvant systemic therapy with chemotherapy, endocrine therapy or anti-HER2 (Human - - Epidermal Growth Factor Receptor 2) treatment is accepted;
Signed informed consent.
You may not be if
Positive surgical margins;
Concomitant chemotherapy;
Supraclavicular or internal mammary nodes metastases;
Distant metastasis;
Previous thoracic radiotherapy;
Bilateral breast cancer;
Patients with collagen diseases;
Unable or unwilling to sign inform consent.
Clareo Health | Hypofractionated Versus Conventional Fractionation Radiotherapy