About this trial
This study is a prospective open-label randomized clinical trial. Following informed consent eligible LASCCHN patients (n=100) planned for CRT will be stratified by tumor p16 status and then randomized in a 1:1 fashion to either concurrent HD cisplatin or concurrent weekly LD cisplatin.
Eligibility criteria
Qualifiers
Age 18 or older
Willing and able to provide written informed consent
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Histologically or cytologically confirmed squamous cell carcinoma
Disqualifiers
Serious medical comorbidities or other contraindications to radiotherapy and/or chemotherapy.
Prior history of head and neck cancer within 5 years.
Nasopharyngeal primary confirmed or suspected.
Severe hearing loss as determined clinically Pre-existing use of hearing aids.
Trial design
Treatments tested in this trial
- High-Dose Cisplatin
- Low-Dose Cisplatin
- Radiotherapy
Treatment groups
Locations
3Sponsors and collaborators
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead sponsor