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A prospective randomized trial comparing hypofractionation with conventional fractionation radiotherapy for T1-2 glottic squamous cell carcinomas : results of a Korean Radiation Oncology Group ( KROG-0201 ) study . BACKGROUND AND PURPOSE To prospectively investigate the effect of radiotherapy fraction size on clinical outcomes in early glottic carcinoma METHODS AND MATERIALS Patients with T1-2 glottic carcinoma were eligible for the protocol . Although 282 patients were required , the study was closed prematurely due to poor accrual with only 156 patients . Of these , 82 patients were allocated to conventional fractionation ( CONV ) arm ( 66 Gy/33 fractions for T1 and 70 Gy/35 fractions for T2 ) , with 74 patients to hypofractionation ( HYPO ) arm ( 63 Gy/28 fractions for T1 and 67.5 Gy/30 fractions for T2 ) . The primary objective was local progression-free survival ( LPFS ) . RESULTS With a median follow-up of 67 months ( range , 2-122 months ) , the 5-year LPFS was 77.8 % for CONV arm and 88.5 % for HYPO arm ( HR 1.55 , p=0.213 ) . No significant difference was observed in the toxicity profile between the two arms . In a subgroup exploratory analysis for T1a disease , the 5-year LPFS trended positively in HYPO arm ( 76.7 % vs. 93.0 % , HR 3.65 , p=0.056 ) . CONCLUSIONS Given that HYPO is at least not inferior to CONV with a similar toxicity profile , the hypofractionation scheme used in this study can be offered to patients with T1-2 glottic carcinoma with potential advantages in terms of local control and a shortened overall treatment time .
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Intervention_Physical
conventional fractionation ( CONV ) arm ( 66 Gy/33 fractions for T1 and 70 Gy/35 fractions for T2 )
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Intervention_Physical
hypofractionation ( HYPO ) arm ( 63 Gy/28 fractions for T1 and 67.5 Gy/30 fractions for T2 )
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Outcome_Physical
effect of radiotherapy fraction size
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Outcome_Mortality
local progression-free survival ( LPFS ) .
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Outcome_Mortality
LPFS
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Outcome_Physical
toxicity profile
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Outcome_Mortality
LPFS
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Participant_Condition
T1-2 glottic squamous cell carcinomas
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Participant_Condition
early glottic carcinoma
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Participant_Condition
Patients with T1-2 glottic carcinoma were eligible
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Participant_Sample-size
282
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Participant_Sample-size
156
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Participant_Condition
patients with T1-2 glottic carcinoma