Low-Dose Weekly vs High-Dose Cisplatin

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.

Eligibility

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.

Conditions2

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