A Randomised Phase II/III Trial of Radiation With High-Dose Cisplatin Every Three Weeks Versus Radiation With Low-Dose Weekly Cisplatin for Patients With Locally Advanced Squamous Cell Head and Neck Cancer
About this trial
The HN009 is currently open at:
- University Hospital Galway
It is planned to open at:
- St. Luke’s Radiation Oncology Network (SLRON)
What is the goal of this study?
This study aims to compare two different ways of giving the chemotherapy drug cisplatin alongside radiation therapy for cancers of the head and neck.
Many centres use either:
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a high dose of cisplatin once every three weeks, or
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a lower dose of cisplatin given every week.
The study wants to learn:
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whether weekly cisplatin causes fewer short-term side effects,
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whether the weekly schedule works just as well at controlling the cancer and helping patients live longer, and
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how each treatment affects quality of life, including hearing and day-to-day wellbeing.
What happens to patients as part of this trial?
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All patients in the study receive radiation therapy to treat their head and neck cancer. A computer then randomly assigns each person to one of two treatment groups:
1. High-dose cisplatin every three weeks: Patients get a larger dose of cisplatin once every three weeks during radiation.
2. Low-dose cisplatin every week: Patients get a smaller dose of cisplatin once every week during radiation.
Participants attend the usual clinic visits for physical exams, blood tests, and checks for side effects.
They may also complete quality-of-life questionnaires, and hearing tests are recommended because cisplatin can affect hearing.
Follow-up continues regularly after treatment to monitor recovery, side effects, hearing, and cancer control.
Who can take part?
You may be eligible if:
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You are 18 years or older.
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You have a confirmed squamous cell cancer of the oropharynx, larynx, hypopharynx, or a p16-positive cancer of unknown primary.
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Your cancer is locally advanced but has not spread to distant parts of the body.
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You are well enough for treatment and have suitable blood, kidney, and liver function.
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Your hearing is tested before treatment (this is recommended).
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You are not pregnant and agree to use effective contraception during treatment.
Study Oversight
Professor Sinead Brennan is the Chief Investigator of the study in Ireland.
The study is sponsored nationally by Cancer Trials Ireland.
NRG Oncology in the US are the international study sponsors and Professor Paul M. Harari is the Sponsor-Investigator.