Low-Dose Weekly vs High-Dose Cisplatin
Recruiting now · Not applicable
Conditions studied: Locally Advanced Head and Neck Squamous Cell Carcinoma
In brief
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.
Key facts
- Study ID
- NCT03649048
- Run by
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- People needed
- 100
- Starts
- 2018-11-05
- Expected to finish
- 2028-09-01
- Last updated by the study team
- 2025-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- Peripheral neuropathy .grade 2 (CTCAE v4.02).
- Prior or planned neoadjuvant chemotherapy prior to CRT.
- Prior head and neck radiation at any time.
- Distant metastatic disease.
- Inability to attend full course of radiotherapy or follow-up visits.
- 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.
- Unable or unwilling to complete QOL questionnaires.
- Pregnant or lactating women.
- Unable to use dual method of contraception.
Where it is running
- Juravinski Cancer Centre — Hamilton, Ontario, Canada (enrolling)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (enrolling)
- London Regional Cancer Program — London, Ontario, Canada
Full record on ClinicalTrials.gov
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