Low-Dose Weekly vs High-Dose Cisplatin

What this study 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.

Who can join (things the study team will check)

✅ You may be able to join 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: 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)
  • 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
• 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 be able to join 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 this trial is running

• Juravinski Cancer Centre, Hamilton, Ontario, Canada
• London Regional Cancer Program, London, Ontario, Canada
• Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Who to contact

Sara Kuruvilla, MD · (519)685-8500 · sara@kuruvilla@lhsc.on.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT03649048.