About this trial
To compare the acute tolerance of highly conformal hypofractionated versus conventional radiotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically-proven diagnosis of squamous cell carcinoma in situ, squamous cell carcinoma, or squamous cell variants (sarcomatoid, verrucous, basaloid, and papillary subtypes) involving the glottic larynx.
Clinical stage 0-II (AJCC, 8th edition) with direct laryngoscopy showing no evidence of greater than stage II true glottic larynx cancer and PET/CT or CT neck showing no evidence of regional disease.
Minimum age is 18 years.
ECOG Performance Status 0-2
Disqualifiers
AJCC stage III or stage IV larynx cancer
Involvement of the arytenoid cartilage beyond the vocal process.
Prior chemotherapy for treatment of the targeted larynx lesion.
Synchronous primaries in the head and neck
Trial design
Sequential
Treatments tested in this trial
LT-SABR
Radiation42.5 Gy in 5 fractions Low-risk: twice/week Moderate-risk: weekly
IMRT
Radiation63 Gy in 28 fractions (T1) 65.25 Gy in 29 fractions (T2)
Treatment groups
Trial outcomes
Primary outcomes
To compare the acute toxicity outcomes between patients treated with highly-conformal hypofractionated radiotherapy and conventional radiotherapy.
Acute toxicity score (i.e. T score), defined as the mean number of grade 2 or higher acute toxicities experienced between the start of radiotherapy and 3 months following treatment.
Sponsors and contacts
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