Low-Dose Weekly vs High-Dose Cisplatin

• Status: Recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.