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Copyright ©2014 Baishideng Publishing Group Inc.
World J Clin Oncol. Aug 10, 2014; 5(3): 425-439
Published online Aug 10, 2014. doi: 10.5306/wjco.v5.i3.425
Table 4 Prospective randomized phase III trials of whole breast radiotherapy vs conventional fractionation radiotherapy
Institution/trialNMedianF/UEligibility criteriaTreatment armsPrimary endpointSecondary endpoint
Royal Marsden Hospital/Sutton and Gloucestershire Oncology Centre[90,91]14105 yr1Invasive breast cancer, T1-3N0-1M0, < 75 yr, BCS (complete macroscopic resection),Level II/III AD50 Gy in 25 fx 39 Gy in 13 fx 42.9 Gy in 13 fxLate changes in breast appearancePalpable breast induration Ipsilateral tumor recurrence
UK START A[92,94]22369.3 yrInvasive breast cancer, T1-3aN0-1M0, > 18 yr, Clear tm margins (≥ 1 mm), No immediate surgical reconstruction, Available for follow-up50 Gy in 25 fx 41.6 Gy in 13 fx 39 Gy in 13 fxLoco-regional tumor recurrenceLate normal tissue effects QOL
UK START B[93,94]22159.9 yrInvasive breast cancer, T1-3aN0-1M0,> 18 yr, Clear tm margins (≥ 1 mm), No immediate surgical reconstruction, Available for follow-up50 Gy in 25 fx 40 Gy in 15 fxLoco-regional tumor recurrenceLate normal tissue effects QOL
Ontario Clinical Oncology Group[95]123412 yrInvasive breast cancer, BCS + Level I/II AD,Tm ≤ 5 cm, Negative axillary nodes, Maximum width of breast tissue ≤ 25 cm, No multicentric disease50 Gy in 25 fx 42.5 Gy in 16 fxLocal recurrenceRegional and distant recurrence Second cancers Breast cosmesis Late toxic effects of radiation