| NCT ID | NCT03649048 |
| Status | Recruiting |
| Phase | — |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Condition | Locally Advanced Head and Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2018-11-05 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2018-11-05 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Sara Kuruvilla, MD
PRINCIPAL INVESTIGATOR
London Health Sciences Centre, London Regional Cancer Program
Frequently Asked Questions
Who can join the NCT03649048 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced Head and Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03649048 currently recruiting?
Yes, NCT03649048 is actively recruiting participants. Contact the research team at sara@kuruvilla@lhsc.on.ca for enrollment information.
Where is the NCT03649048 trial being conducted?
This trial is being conducted at Hamilton, Canada, London, Canada, Toronto, Canada.
Who is sponsoring the NCT03649048 clinical trial?
NCT03649048 is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The principal investigator is Sara Kuruvilla, MD at London Health Sciences Centre, London Regional Cancer Program. The trial plans to enroll 100 participants.