ArticleInternational journal of radiation oncology, biology, physics2024
HYPORT: Phase 1 Study of 3-Week Hypofractionated Postoperative Radiation Therapy for Head and Neck Squamous Cell Carcinoma.
Article in International journal of radiation oncology, biology, physics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed, 9 citations in OpenAlex.
- Commencement of Hypofractionated Adjuvant Radiation Therapy in Intermediate-Risk Oral Cavity Cancer: A Phase 1 Study Protocol (CHARIOT-1).Advances in radiation oncology · 2026Article
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Authors and funding
10 authors at 2 institutions in 1 country.
Funding
Abstract
purposeShortening the overall radiation therapy (RT) treatment time has advantages in cost and treatment burden, but data on hypofractionated RT in head and neck squamous cell carcinoma are limited. This study assessed the safety of moderately hypofractionated RT in the postoperative setting. METHODS AND MATERIALS: Patients with completely resected stage I-IVB squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx with intermediate risk factor(s) including T3/4 disease, positive lymph node(s), close margin(s), perineural invasion, and/or lymphovascular invasion were enrolled on a rolling 6-design phase 1 study. Levels 0 and 1 consisted of 46.5 Gy in 15 fractions delivered 5 days a week and 44.4 Gy in 12 fractions delivered 4 days a week, respectively. The primary endpoint was maximum tolerated dose/fractionation of moderately hypofractionated postoperative RT.
resultsTwelve patients were enrolled with 6 each on levels 0 and 1. No patient experienced a dose-limiting toxicity or grade 4 to 5 toxicity. Acute grade 3 toxicity occurred in 2 patients on level 0 (weight loss, neck abscess) and 3 patients on level 1 (all oral mucositis). One patient on level 0 experienced late grade 3 toxicity (persistent neck abscess). With a median follow-up of 18.6 months, 2 patients on level 1 had a recurrence: a regional recurrence in the undissected, unirradiated contralateral neck from a well-lateralized tonsil primary and an in-field local recurrence of oral tongue primary. The maximum tolerated dose/fractionation was determined to be 44.4 Gy in 12 fractions, but owing to more favorable tolerability in the setting of equivalent biologically effective dose, 46.5 Gy in 15 fractions was deemed the recommended phase 2 dose/fractionation.
conclusionsModerately hypofractionated RT delivered over 3 weeks is well tolerated in the short term in this phase 1 cohort of patients with head and neck squamous cell carcinoma following surgical resection. The follow-up phase 2 randomized trial will deliver 46.5 Gy in 15 fractions as the experimental arm.
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