Status:
ACTIVE_NOT_RECRUITING
Vocal-cord vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
London Health Sciences Centre
M.D. Anderson Cancer Center
Conditions:
Cancer Neck
Larynx Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 12 2026
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT03759431
Start Date
October 11 2018
End Date
December 12 2026
Last Update
March 21 2025
Active Locations (3)
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1
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
2
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
3
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 1R6