NIMRAD (A Randomised Placebo-controlled Trial of Synchronous NIMorazole Versus RADiotherapy Alone in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Not Suitable for Synchronous Chemotherapy or Cetuximab)

Inclusion Criteria: * Histologically confirmed (newly diagnosed/ not recurrent) head and neck squamous cell carcinoma; all primary subsites EXCEPT nasal cavity, oral cavity, nasopharynx and paranasal sinus (i.e. oropharynx, hypopharynx, larynx are allowed) * Stage T3/T4 N0; any node +ve case including T1 node +ve; T2N0 base of tongue/hypopharynx * Patients suitable for definitive radiotherapy. Block dissections may be performed pre-RT for N2/N3 disease * WHO status 0-2 * Patient fit and able to undergo RT with nimorazole and be expected to complete treatment * Absence of another disease or previous malignancy which is likely to interfere with the treatment or assessment of response * No evidence of distant metastases (M0) * Unable to tolerate/unlikely to benefit from platinum chemotherapy or monoclonal antibody therapy * Women must be postmenopausal (no menstrual period for a minimum of 1 year) or have a negative serum pregnancy test on entry in the study (even if surgically sterilised) and be using an adequate contraception method. This must be continued for 1 week after completion of nimorazole, unless child bearing potential has been terminated by surgery/radical radiotherapy * Men must be willing to use an adequate method of contraception during treatment and until 1 week after nimorazole * Greater than 18 years of age; no upper age limit * Available for follow up within the United Kingdom * Adequate renal and liver function - absolute neutrophil count \>=1.5 x 109/L, creatinine \<=2x ULN, platelets \> 100x109/L, total bilirubin \<=2 x ULN, AST or ALT \<3 x ULN * The capacity to understand the patient information sheet and the ability to provide written informed consent * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures Exclusion Criteria: * Patients with T1N0 tumours or those within the nasopharynx, nasal cavity or sinus, oral cavity; T2No larynx and tonsil; unknown primary cancer. * Any prior chemotherapy in the last 6 months or RT within the planned radiation field * Presence of any life threatening illness such as unstable angina or severe chronic obstructive pulmonary disease * Mental disability or patient otherwise unable to give informed consent and/or complete patient questionnaires * Hb \<100 g/l (patients with anaemia may be transfused to bring Hb levels to \>100 g/l within 1 week of treatment start. Please repeat Hb following transfusion to confirm now eligible) * Peripheral neurophathy as assessed clinically (CTCAE \>=2) * Use of any investigational drug within 30 days prior to screening * Severe and/or uncontrolled medical disease * Any malabsorption syndrome (i.e. partial gastrectomy, small bowel resection, Crohn's disease or ulcerative colitis) * Use of Lithium or Phenobarbitone during the study * Patients who are breastfeeding or pregnant * Previous malignancy within 5 years (except BCC, in-situ Ca e.g. of the cervix) * Previous definitive surgery to primary site