Vocal Cord Only Hypofractionated Radiotherapy vs Whole Laryngeal Radiotherapy for T1aN0 Glottic Cancer

Status: Unknown
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• T10N0 glottic squamous cell carcinoma

• Ability to provide written informed consent

• Eastern Cooperative Oncology Group performance status 0-2

Locations
Other Locations
Egypt
National Cancer Institute, Cairo University
RECRUITING
Cairo
Contact Information
Primary
Mohamed Mortada Elsharief
drmohamedelcherif@gmail.com
+0201128512966
Time Frame
Start Date: 2020-01-01
Completion Date: 2023-12-01
Participants
Target number of participants: 50
Treatments
Experimental: Single vocal cord hypofractionated radiotherapy
Hypofractionated radiotherapy 58.08Gy/16 fractions to affected vocal cord plus margins to account for motion and setup errors using IMRT/VMAT technique
Active_comparator: Whole laryngeal radiotherapy
Radiotherapy 63Gy/28 fractions to whole larynx from lower border of hyoid bone to lower border of cricoid cartilage using IMRT/VMAT technique
Related Therapeutic Areas
Sponsors
Collaborators: Cairo University
Leads: National Cancer Institute, Egypt

This content was sourced from clinicaltrials.gov