Actively Recruiting
Low-Dose Weekly vs High-Dose Cisplatin
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
512 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Low-Dose Weekly vs High-Dose Cisplatin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older
- Able and willing to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Histologically or cytologically confirmed squamous cell carcinoma
- Primary tumor located in oral cavity, oropharynx, nasal cavity, salivary glands (excluding parotid), hypopharynx, larynx, or unknown primary
- Suitable for high-dose cisplatin based on tumor and clinical condition
- Planned to receive radical intent radiation treatment as judged by the radiation oncologist
- Adequate organ and marrow function with hemoglobin > 80 g/L, neutrophils > 1.5x10^9/L, platelets > 100x10^9/L, bilirubin < 35 umol/L, AST or ALT < 3 times upper limit, creatinine clearance > 50 ml/min
- Assessment by multidisciplinary head and neck cancer clinic and tumor board prior to randomization
You will not qualify if you...
- Serious medical conditions or contraindications to radiotherapy or chemotherapy
- History of head and neck cancer within past 5 years
- Confirmed or suspected nasopharyngeal primary tumor
- Severe hearing loss or current use of hearing aids
- Peripheral neuropathy grade 2 or higher
- Prior or planned neoadjuvant chemotherapy before chemoradiotherapy
- Previous head and neck radiation therapy
- Distant metastatic disease
- Unable to attend all radiotherapy and follow-up visits
- Prior invasive cancer 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 breastfeeding
- Unable to use dual contraception methods
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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