Comparing low-dose and high-dose cisplatin for head and neck cancer treatment

Randomized Trial Comparing Low-Dose Weekly to High-Dose Cisplatin Concurrent With Radiation for Locally Advanced Head and Neck Cancer.

This study is testing whether giving lower doses of cisplatin can help people with advanced head and neck cancer avoid serious side effects, like hearing loss, while still getting effective treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 3 sites (Hamilton, Ontario and 2 other locations)
• Trial ID: NCT03649048 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective open-label randomized trial that aims to compare the effects of low-dose weekly cisplatin versus high-dose cisplatin in patients with locally advanced head and neck squamous cell carcinoma (LASCCHN) undergoing chemoradiotherapy. Eligible patients will be stratified by tumor p16 status and randomized in a 1:1 fashion to receive either treatment. The study focuses on minimizing long-term side effects associated with cisplatin, particularly hearing loss, which can significantly impact the quality of life for younger patients who are more likely to survive and contribute to society. The trial seeks to identify risk factors for cisplatin toxicity and improve treatment individualization.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 or older with histologically confirmed squamous cell carcinoma of specific head and neck sites who are suitable for cisplatin therapy.

Not a fit: Patients with significant comorbidities or those not suitable for cisplatin therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and less toxic treatment options for patients with head and neck cancer.

How similar studies have performed: Previous studies have explored cisplatin toxicity and treatment strategies, but this specific comparison of low-dose versus high-dose cisplatin in this patient population is novel.

Eligibility 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.

Where this trial is running

Hamilton, Ontario and 2 other locations

• Juravinski Cancer Centre — Hamilton, Ontario, Canada (RECRUITING)
• London Regional Cancer Program — London, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Sara Kuruvilla, MD — London Health Sciences Centre, London Regional Cancer Program
• Study coordinator: Sara Kuruvilla, MD

Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma