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Intervention protocol 03b

Hypofractionated adjuvant radiotherapy in node-negative early breast cancer - a randomized trial from the Danish Breast Cancer Group (DBCG)

Objectives In Denmark standard adjuvant radiotherapy (RT) after lumpectomy is 48 Gy in 24 fractions to the residual breast. Results from a large randomised phase III trial have suggested that the local relapse rate is similar for patients treated with either 50 Gy in 25 fractions or 40 Gy in 15 fractions (START trial). The morbidity was reported identical for the two treatment arms. Our protocol will investigate this new hypofractio¬nated schedule for whole breast irradiation.
Study outline (intervention) All women operated with breast-conserving procedure for pN0 early breast cancer will be offered randomization between conventional 48 Gy in 24 fractions versus 40 Gy in 15 fractions. The study will be running from Oct. 2008 and the aim is to randomize 600 patients in 3 years and follow them for at least another 3 years. All radiotherapy departments in Denmark will participate. Morbidity related to normal tissue in the breast, heart, lung, thorax wall and ribs are the primary outcome measures. Secondary endpoints include loco-regional control, disease free survival and overall survival. Morbidity will be scored by the DBCG morbidity system Prognostic and predictive statistical models including volumetric, dosimetric, clinical and biological risk factors as wells radiobiological parameter estimates will be used to allow precise risk estimation in individual patients.
Expected impact Hypofractionated whole breast irradiation will spare the patient 9 treatments and she will thus hopefully be able to recover more quickly.
Linkages with work packages WP 1, 9. Tools from WP1 will be used to obtain knowledge of the tumour biology within the breast target and the adjacent normal tissues.