RecruitingNot ApplicableNCT03649048

Low-Dose Weekly vs High-Dose Cisplatin

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

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrollment

100 participants

Start Date

Nov 5, 2018

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two ways of giving the chemotherapy drug cisplatin alongside radiation therapy for head and neck cancer: a lower dose given weekly versus a higher dose given every three weeks, to find out which is safer and more effective. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with squamous cell carcinoma (a type of cancer) in the head or neck area (such as the mouth, throat, voice box, nasal cavity, or nearby areas) - Your cancer has been confirmed by biopsy - You are in good physical health (able to perform normal daily activities with some limits) - You are willing to give written consent **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body (metastatic) - You have had prior radiation to the head or neck area - You have serious kidney, hearing, or nerve problems that make cisplatin unsafe - You are pregnant - You have certain other significant medical conditions that would make chemotherapy risky Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHigh-Dose Cisplatin

Intravenous administration of High-Dose Cisplatin

DRUGLow-Dose Cisplatin

Intravenous administration of Low-Dose Cisplatin

RADIATIONRadiotherapy

Participating centres are to follow their local radiation treatment planning and delivery techniques.

Locations(3)

Juravinski Cancer Centre

Hamilton, Ontario, Canada

London Regional Cancer Program

London, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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NCT03649048

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