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Not yet recruitingNCT07197060Updated Sep 29, 2025

Hypofractionated Radiotherapy With 3.5 Gy Per Fraction for Early Glottic Cancer

An observational study in Early Glottic Cancer, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-29.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
18 Years and older
Sex
All
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Study 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

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Conditions studied

  • Early Glottic Cancer
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In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients with histologically confirmed squamous cell carcinoma of the glottisStage T1-T2N0M0 (AJCC 8th edition)based on clinical exam and imaging

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • study group

    Histologically confirmed squamous cell carcinoma of the glottis

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What researchers measure

Primary outcomes

  1. local control rate

    local control rate

    Time frame: 2-year

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07197060
Lead sponsor
Assiut University
Responsible party
Manar Tarek mohamed (residant doctor at Assiut university hospital, Assiut University) — Principal investigator
First posted
Sep 29, 2025
Start date
Oct 1, 2025 (estimated)
Primary completion
Oct 1, 2026 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Sep 29, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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