Low-Dose Weekly vs High-Dose Cisplatin

Launched by LONDON HEALTH SCIENCES CENTRE RESEARCH INSTITUTE OR LAWSON RESEARCH INSTITUTE OF ST. JOSEPH'S · Aug 24, 2018

Keywords

ClinConnect Summary

This clinical trial is studying two different ways of giving a chemotherapy drug called cisplatin to patients with locally advanced head and neck squamous cell carcinoma, a type of cancer that can affect areas like the mouth and throat. The goal is to compare low-dose weekly cisplatin with high-dose cisplatin given at the same time as radiation therapy, which is a common treatment for this cancer. The trial aims to find out which method is more effective and has fewer side effects for patients.

To participate in this trial, you need to be at least 18 years old and have a confirmed diagnosis of squamous cell carcinoma in specific areas of the head and neck. You should be in good overall health, not having serious other medical conditions, and be able to attend all treatments and follow-up visits. If you join the trial, you will be randomly assigned to receive either the low-dose or high-dose cisplatin during your radiation therapy. The study is currently recruiting participants, and your healthcare team will guide you through the process and provide support.

Gender

ALL

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.