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Not Yet RecruitingNCT07197060

Hypofractionated Radiotherapy With 3.5 Gy Per Fraction for Early Glottic Cancer

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
70 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

Conditions

Timeline

Start date
2025-10-01
Primary completion
2026-10-01
Completion
2027-10-01
First posted
2025-09-29
Last updated
2025-09-29

Source: ClinicalTrials.gov record NCT07197060. Inclusion in this directory is not an endorsement.