Randomized Trial of Hyperfractionation versus Conventional Fractionation in T2 Squamous Cell Carcinoma of the Vocal Cord (RTOG 9512)
Abstract
Purpose To compare hyperfractionation versus standard fractionation for T2N0 vocal cord carcinoma in a randomized controlled trial. Methods and Materials Patients with T2 vocal cord cancer were stratified by substage (T2a vs. T2b) and randomly assigned to receive either hyperfractionation (HFX) to 79.2 Gy in 66 fractions of 1.2 Gy given twice a day, or standard fractionation (SFX) to 70 Gy in 35 fractions given once a day. The trial was designed to detect a 55% reduction in the local failure hazard rate with 80% statistical power. Results Between April 1996 and July 2003, 250 patients were enrolled. Of 239 patients analyzable for outcomes, 94% were male, 83% had KPS 90-100, and 62% had T2a tumor. Median follow-up for all surviving patients was 7.9 years (range: 0.6 – 13.1). The 5-year local control (LC) rate was 8 points higher (but not statistically significant: p=0.14) for HFX (78%) vs SFX (70%), corresponding to a 30% hazard rate reduction. Five-year disease-free survival (DFS) was 49% vs 40% (p=0.13) and overall survival (OS) 72% vs 63% (p=0.29). HFX had higher rates of acute skin, mucosal, and laryngeal toxicity. Grade 3-4 late effects were similar with 5-year cumulative incidence of 8.5% (3.4-13.6%) after SFX and 8.5% (3.4-13.5%) after HFX. Conclusions Five-year local control was modestly higher with HFX compared to SFX for T2 glottic carcinoma, but the difference was not statistically significant. These results are consistent with prior studies of hyperfractionation…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 239 participants or records.
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