Hypofractionated Radiotherapy With 3.5 Gy Per Fraction for Early Glottic Cancer

NCT ID: NCT07197060

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-10-01

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

Conditions

Early Glottic Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

study group

Histologically confirmed squamous cell carcinoma of the glottis

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Manar Tarek mohamed

residant doctor at Assiut university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Hypofractionated 3.5 Gy Gc

Identifier Type: -

Identifier Source: org_study_id