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NCT07197060

Hypofractionated Radiotherapy With 3.5 Gy Per Fraction for Early Glottic Cancer

Not yet recruiting Last updated 29 September 2025
What this trial tests

trial in Early Glottic Cancer in 70 participants. Not yet recruiting.

Timeline
1 October 2025
Primary endpoint
1 October 2026
1 October 2027

Quick facts

Lead sponsorAssiut University
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment70
Start date1 October 2025
Primary completion1 October 2026
Estimated completion1 October 2027

Conditions studied

Sponsor

Assiut University

Who can join

18 and older, any sex, with Early Glottic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Early-stage glottic carcinoma (T1-T2N0M0) is typically managed with either transoral laser microsurgery or definitive radiotherapy, both providing excellent local control rates and voice preservation outcomes. Radiotherapy remains a widely adopted non-invasive option, particularly for patients with bilateral disease or poor surgical candidacy. Traditionally, conventional fractionation schemes of 2.0-2.25 Gy per fraction over 6-7 weeks have been standard; however, emerging evidence supports the use of hypofractionated radiotherapy (HFRT) as an effective and more convenient alternative in this setting. The unique anatomical confinement of early glottic tumors, along with their low propensity for lymphatic spread, makes them ideal candidates for dose escalation using hypofractionation. Several retrospective and prospective studies have demonstrated that higher doses per fraction (2.5-3.5 Gy) can yield comparable or superior local control rates compared to conventional regimens, without significantly increasing toxicity. The incorporation of modern techniques such as Intensity Modulated RadioTherapy (IMRT) and Simultaneous Integrated Boost (SIB) has further.enabled safe and precise delivery of escalated doses to the primary lesion while sparing nearby organs-at-risk (OARs) Recent data have shown that a 3.5 Gy per fraction regimen (totaling 59.5 Gy in 17 fractions) achieves excellent tumor control with favorable toxicity profiles in selected patients. Additionally, omission of the posterior commissure from the elective target volume in the absence of direct tumor extension has been associated with reduced mucosal toxicity and improved patient-reported outcomes. Therefore,hypofractionated RT using 3.5 Gy per fraction offers a promising voice-preserving strategy in the treatment of early glottic cancer

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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