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Hypofractionated Radiotherapy With 3.5 Gy Per Fraction for Early Glottic Cancer

Hypofractionated Radiotherapy With 3.5 Gy Per Fraction for Early Glottic Cancer

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07197060
Enrollment
70
Registered
2025-09-29
Start date
2025-10-01
Completion date
2027-10-01
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Glottic Cancer

Brief 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

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* • Histologically confirmed squamous cell carcinoma of the glottis * Stage T1-T2N0M0 (AJCC 8th edition) * (based on clinical exam and imaging) * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * No prior radiotherapy or surgery to the larynx (except biopsy) * Adequate organ function and a life expectancy of at least 6 months * Ability to comply with follow-up schedule and complete voice assessments * Signed informed consent

Exclusion criteria

* • Prior head and neck irradiation * Nodal involvement or distant metastasis * Poor vocal cord mobility or subglottic extension * Severe comorbidities or life expectancy \< 6 months

Design outcomes

Primary

MeasureTime frameDescription
local control rate2-yearlocal control rate

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026