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A blind randomized multicentre study of accelerated fractionated chemo-radiotherapy with or without the hypoxic cell radiosensitizer nimorazole (Nimoral), using a 15-gene signature for hypoxia in the treatment of squamous cell carcinoma of the head and neck.

The drug nimorazole belongs to a class of chemicals known as 5-nitroimidazoles. Drugs from this class are used against infection. In addition, nimorazole makes tumour cells more sensitive to radiotherapy. Therefore, the investigators want to find out whether the addition of nimorazole to the standard treatment with radiotherapy in combination with chemotherapy with cisplatin shows activity against Locally Advanced Head and Neck HPV Negative Squamous Cell Cancers and is safe. Furthermore, the investigators will investigate if a specific examination done with tumour tissue will help to predict whether the treatment will work or not.

Primary Sponsor

European Organisation for Research and Treatment of Cancer (EORTC)

Collaborating Groups

Trans Tasman Radiation Oncology Group (TROG), Danish Head and Neck Cancer Group (DAHANCA)

Final Accrual

212

Closing Date of Accrual

February 2018

Trial Chairperson

Dr Howard Liu, Princess Alexandra Hospital, QLD

Trial Contact

EORTC1219@trog.com.au

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