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 tumor 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 your type of head and neck cancer and is safe.
Furthermore the investigators will investigate if a specific examination done with your tumor
tissue will help to predict whether the treatment will work or not.
To find out if the activity observed with this treatment is not caused by chance alone, the
investigators need to obtain data from patients who receive this treatment and from patients
who receive other treatments.
The data from these two groups of patients will be compared to see which treatment is better.
Participants will be split into 2 groups. Each group will receive different treatments. The
treatment each group receives is determined by chance using a computer program. This works
like flipping a coin and is called randomization. This helps to make sure that groups of
patients are similar when the study starts. Neither you, your study doctor, nor the study
staff can influence in which group you will be placed or which treatment you will receive.
If allocated to group 1, Patient will receive radiotherapy in combination with chemotherapy
with cisplatin and nimorazole as a pill. This is considered the 'experimental' treatment.
If allocated to group 2, patient will receive radiotherapy in combination with chemotherapy
with cisplatin and a so called 'placebo' as a pill. The placebo is a dummy treatment. It
looks like the real one, but it is not. It contains no active ingredient/medicine.
Phase:
Phase 3
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC