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