Hypofractionated Versus Conventional Fractionation Radiotherapy

Hypofractionated Versus Conventional Fractionation Radiation After Conservative Surgery or Mastectomy With Irradiation of Lymph Node Drainage: a Phase II Randomized Clinical Trial for the Evaluation of Acute Toxicity

This study was designed to evaluate the acute toxicity and quality of life of hypofractionated radiation versus conventional when regional node irradiation is indicated after breast-conserving surgery or mastectomy.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.