Vocal-cord vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/5/2018
Start Date:October 11, 2018
End Date:December 12, 2024
Contact:Diane Trudel
Email:diane.dt.trudel.chum@ssss.gouv.qc.ca
Phone:514-890-8000

Use our guide to learn which trials are right for you!

A Randomized Study of Vocal-cord Only vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer

This is a multicentrer, randomized Bayesian Phase II trial for patients with early stage
(T1N0) glottic squamous cell carcinoma treated with radical radiotherapy. The primary
objective is to assess the non-inferiority of local control achieved with vocal-cord only
radiotherapy (VC-RT) compared to complete larynx radiotherapy (CL-RT) in T1N0 glottic
laryngeal squamous cell cancer, measured at 2-years after treatment. Secondary outcomes
include overall survival, as well as voice impairment, dysphagia and quality of life,
measured respectively by the voice handicap index -10 (VHI-10), the MD Anderson Dysphagia
Inventory (MDADI) and the MD Anderson Symptom Inventory- Head and Neck module (MDASI-HN).
Patients will be randomized in a 1:3 ratio to CL-RT (39 patients) and VC-RT (116 patients)
arms. There will be stratification by tumor stage (T1a/T1b) and by institution. An interim
analysis is planned after the first 55 patients enrolled on the experimental arm have a
6-month follow-up.


Inclusion Criteria:

- Stage T1a-b N0 of the true vocal cords planned for definitive RT

- Patient not candidate for laser surgery or declined laser surgery

- Biopsy-confirmed squamous cell carcinoma, including verrucous carcinoma

- Eastern Cooperative Oncology Group performance status 0-2

- Ability to provide written informed consent.

Exclusion Criteria:

- Previous irradiation of the head and neck (HNC) region

- Pregnancy or breastfeeding

- Any medical condition that represents, in the opinion of the investigator, a
contraindication to radiotherapy or would prevent follow-up after radiotherapy.

- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
for a minimum of 2 years.
We found this trial at
2
sites
London, Ontario
Principal Investigator: David Palma
Phone: 519-685-8500
?
mi
from
London,
Click here to add this to my saved trials
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: David I Rosenthal
Phone: 877-832-6789
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
?
mi
from
Houston, TX
Click here to add this to my saved trials