Actively Recruiting
Randomized Trial Comparing Low-Dose Weekly to High-Dose Cisplatin Concurrent With Radiation for Locally Advanced Head and Neck Cancer
Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2025-07-31
100
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatment options for patients with locally advanced head and neck squamous cell carcinoma (LASCCHN), focusing on comparing different dosing schedules of cisplatin chemotherapy combined with radiation. The study aims to resolve uncertainty about the best cisplatin dosing method to reduce hearing loss and improve quality of life in patients undergoing chemoradiotherapy. This trial also explores genetic factors that may influence the risk of hearing damage from cisplatin treatment. Participants will be randomly assigned to receive either high-dose cisplatin given on days 1, 22, and 43 or a low-dose weekly cisplatin schedule, both administered intravenously alongside radiation therapy. The radiation treatment follows local planning and delivery standards at participating centers. The study includes a prospective, open-label design with 100 patients grouped by tumor p16 status. During the study, participants will undergo assessments including hearing-related quality of life evaluations up to one year after treatment starts. Researchers will monitor hearing loss severity, neuropathy, kidney function, and genetic markers at multiple time points. Quality of life questionnaires and clinical exams will be completed, along with long-term follow-up to assess treatment impact and safety. The total participation duration includes baseline, treatment, and up to one year of post-treatment observation.
CONDITIONS
Brief Title
Low-Dose Weekly vs High-Dose Cisplatin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older
- Willing and able to provide written informed consent
- ECOG performance status 0-2
- Histologically or cytologically confirmed squamous cell carcinoma
- Primary tumor site includes oral cavity, oropharynx, nasal cavity, salivary glands (excluding parotid), hypopharynx, larynx, or unknown primary
- Suitable for high-dose cisplatin therapy based on tumor and clinical evaluation
- Planned to receive radical intent radiation treatment
- Adequate organ and marrow function with specific blood count and kidney function thresholds
- Assessed at head and neck cancer multidisciplinary clinic and presented at tumor board prior to randomization
You will not qualify if you...
- Serious medical comorbidities or contraindications to radiotherapy/chemotherapy
- Prior head and neck cancer within 5 years
- Nasopharyngeal primary confirmed or suspected
- Severe hearing loss or pre-existing use of hearing aids
- Peripheral neuropathy grade 2 or higher
- Prior or planned neoadjuvant chemotherapy before chemoradiotherapy
- Prior head and neck radiation at any time
- Distant metastatic disease
- Inability to attend full radiotherapy or follow-up visits
- Prior invasive malignant disease unless disease-free for 5 years or more (except non-melanoma skin cancer or in-situ carcinoma)
- Unable or unwilling to complete quality of life questionnaires
- Pregnant or lactating women
- Unable to use dual method of contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 7 weeks (duration of chemoradiotherapy)
Participants receive either weekly low-dose cisplatin or high-dose cisplatin on days 1, 22, and 43 concurrently with radiation therapy as part of their cancer treatment.
3 to 7 visits depending on cisplatin dosing schedule
Duration - Up to 1 year
Participants are monitored for hearing-related quality of life and treatment-related side effects including hearing loss and neuropathy for up to 1 year after starting treatment.
Visits at 6 months and 1 year post start of treatment
Trial Site Locations
Total: 3 locations
1
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8N 3Z5
Actively Recruiting
2
London Regional Cancer Program
London, Ontario, Canada, N6A 5W9
Active, Not Recruiting
3
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
Research Team
S
Sara Kuruvilla, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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