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Trial Title:
Vocal Cord vs Whole Laryngeal Radiotherapy for T1aN0 Glottic Cancer
NCT ID:
NCT05679856
Condition:
Larynx Cancer Stage I
Glottic Carcinoma
Conditions: Official terms:
Laryngeal Neoplasms
Conditions: Keywords:
Larynx
Glottic
T1
hypofractionated radiotherapy
Vocal cord
Laryngeal carcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Hypofractionated single vocal cord irradiation
Description:
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
Arm group label:
Single vocal cord hypofractionated radiotherapy
Intervention type:
Radiation
Intervention name:
Whole laryngeal radiotherapy
Description:
The whole larynx from lower border of hyoid bone to lower border of cricoid cartilage
will receive 63Gy/28 fractions using IMRT/VMAT technique
Arm group label:
Whole laryngeal radiotherapy
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.
Detailed description:
Most laryngeal cancers present in early stage and more than two thirds of it occur in the
glottic region(T1-T2). Early glottic carcinoma is historically treated with conventional
radiotherapy using large box fields (from lower border of hyoid to lower border of
cricoid), using wedged parallel opposed photon beams. In spite of good local control rate
of more than 90% for T1a glottic cases, the tumor-free contralateral vocal cord,
arytenoids, thyroid cartilage, and all muscles responsible for opening and closing the
vocal cords, the swallowing muscles, carotid arteries and thyroid gland are exposed to
high radiation doses (fully or partially) which could lead to an increased probability of
complications that negatively influence the quality of life of these patients. Typical
complications have involved voice/ speech impairment, diet problems (swallowing,
trismus), arytenoids edema, an increased risk of strokes, and reduced treatment options
for previously irradiated patients. Many studies showed that increasing fraction size and
shortening the overall treatment time (hypofractionated radiotherapy) could result in
better local control of T1 glottic cancer The use of 63Gy/28 Fractions(Fx) showed
superior local control compared with conventional use of 66Gy/33Fx with shorter overall
treatment time. Based on this study this dose is the standard in our institute. In
contrast to the traditional radiotherapy principle to treat the whole larynx, surgical
laser excision of T1a glottic cancer involves removal of gross tumor with minimal, often
sub-millimeter, excisional margins with good oncological outcome and good quality of
voice. Similar to this surgical concept and with modern radiotherapy IMRT/VMAT technique,
the approach of single vocal cord irradiation (SVCI) was introduced. A study of 30
patients with T1a glottis cancer treated by image guided vocal cord radiotherapy was
published in 2015 and it showed 100% local control at 2 years and with no grade 3
toxicities reported and better quality of voice when compared to historical cohorts
Dosimetric analysis showed that IMRT resulted in markedly reducing the dose to
contralateral cord, arytenoids, thyroid cartilage, inferior constrictor muscle and
carotid arteries. To date no prospective phase 3 trial was done to compare treatment
outcome and toxicity profile of vocal cord only hypofractionated radiotherapy vs
traditional whole laryngeal radiotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- T10N0 glottic squamous cell carcinoma
- Ability to provide written informed consent
- Eastern Cooperative Oncology Group performance status 0-2
Exclusion Criteria:
- Previous head and neck irradiation.
- WHO performance status above 2.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Institute, Cairo University
Address:
City:
Cairo
Zip:
11796
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Mohamed Mortada Elsharief
Phone:
+0201128512966
Email:
drmohamedelcherif@gmail.com
Start date:
January 1, 2020
Completion date:
December 1, 2023
Lead sponsor:
Agency:
National Cancer Institute, Egypt
Agency class:
Other
Collaborator:
Agency:
Cairo University
Agency class:
Other
Source:
National Cancer Institute, Egypt
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05679856
