Breast Cancer Clinical Trial
Official title:
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.
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