Comparing low-dose and high-dose cisplatin with radiation for head and neck cancer
Compares two cisplatin doses given with radiation in advanced head and neck cancer.
Plain-language title generated from the registry record
Registry title: Low-Dose Weekly vs High-Dose Cisplatin
Key facts
- Where
- Hamilton, London, and Toronto, CanadaSee the 3 sites
Where in Canada
- Juravinski Cancer CentreHamilton, CanadaTaking people
- London Regional Cancer ProgramLondon, CanadaNo longer taking part
- Sunnybrook Health Sciences CentreToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Trial code
- NCT03649048
- Record updated
- 31 July 2025
- Original description
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.Read full original descriptionShow less
Randomized Trial Comparing Low-Dose Weekly to High-Dose Cisplatin Concurrent With Radiation for Locally Advanced Head and Neck Cancer.
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.
Inclusion: 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; Primary tumor site includes oral cavity, oropharynx, nasal cavity, salivary glands (excluding parotid), hypopharynx, or larynx and primary unknown; Patients must be deemed suitable for HD cisplatin therapy based on tumor characteristics, clinical condition and comorbidities in the judgement of the treating medical oncologist; Patients must be planned to receive radical intent radiation treatment based on clinical condition, comorbidities and tumor characteristics in the judgment of the treating radiation oncologist; Adequate organ and marrow function independent of transfusion for at least 7 days prior to randomization defined as:; Hemoglobin > 80 g/L; Absolute neutrophil count >1.5x10⁹ /L, platelets >100x10⁹/L; Bilirubin < 35 umol/L; AST or ALT < 3 x the upper limit of normal; Calculated creatinine clearance (as determined by Cockcroft- Gault) > 50 ml/min; Males:; Creatinine Clearance = Weight (kg) x (140 - Age) (mL/min) 72 x serum creatinine (mg/dL); Females:; Creatinine Clearance = Weight (kg) x (140 - Age) x 0.85 (mL/min) 72 x serum creatinine (mg/dL); Patient must be assessed at head and neck cancer multidisciplinary clinic (with assessment by radiation oncologist and surgeon) and presented at multidisciplinary tumor board prior to randomization.
Exclusion: Serious medical comorbidities or other contraindications to radiotherapy and/or chemotherapy; Prior history of head and neck cancer within 5 years; Prior or planned neoadjuvant chemotherapy prior to CRT; Prior head and neck radiation at any time; Inability to attend full course of radiotherapy or follow-up visits; Distant metastatic disease; Prior invasive malignant disease unless disease-free for at least 5 years or more, with the exception of non-melanoma skin cancer or in-situ carcinoma; Nasopharyngeal primary confirmed or suspected; Severe hearing loss as determined clinically Pre-existing use of hearing aids; Peripheral neuropathy .grade 2 (CTCAE v4.02); Unable or unwilling to complete QOL questionnaires; Pregnant or lactating women; Unable to use dual method of contraception.