TROG 14.03 (EORTC 1219)

Primary sponsor: European Organisation for Research and Treatment of Cancer (EORTC)
Collaborating group: Trans Tasman Radiation Oncology Group (TROG), Danish Head and Neck Cancer Group (DAHANCA)

Title

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

Summary

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.

Final Accrual 

194 Randomised (212 Registered)

Trial Status

Closed to accural, February 2018

Trial chairperson

Professor Sandro Porceddu, Princess Alexandra Hospital, QLD

Trial contact

Patrick Wheeler
TROG Trial Coordinating Centre
Phone: +61 2 4014 3903
Email: EORTC1219@trog.com.au

Further information

Clinical Trials.gov Registry - NCT01880359

Trial resources for TROG members

TROG 14.03 member page