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Vocal Cord vs Whole Laryngeal Radiotherapy for T1aN0 Glottic Cancer

NCT05679856 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-01-11

No results posted yet for this study

Summary

The primary objective of this prospective randomized clinical trial is to assess non inferiority in terms of local control achieved with single vocal cord hypofractionated radiotherapy compared to standard of care whole laryngeal radiotherapy in patients with T1aN0 glottic cancer . Secondary objectives include overall survival rate and to compare the Voice Handicap Index score between the 2 arms as well as acute and late toxicities. Patients are randomized in 1:1 ratio.

Conditions

  • Larynx Cancer Stage I
  • Glottic Carcinoma

Interventions

RADIATION

Hypofractionated single vocal cord irradiation

Only the affected vocal cord with additional margin to account for motion and setup errors will receive 58.08Gy/16 fractions using IMRT/VMAT technique

RADIATION

Whole laryngeal radiotherapy

The whole larynx from lower border of hyoid bone to lower border of cricoid cartilage will receive 63Gy/28 fractions using IMRT/VMAT technique

Sponsors & Collaborators

  • Cairo University

    collaborator OTHER

  • National Cancer Institute, Egypt

    lead OTHER

Principal Investigators

  • Mohamed Mortada Elsharief · NCI, Cairo University, Egypt

  • Tarek Shouman · NCI, Cairo University, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2023-12-01
Completion
2023-12-01
FDA Device
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05679856 on ClinicalTrials.gov