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)

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: the purpose of this study is to see whether adding nimorazole to standard radiotherapy benefits patients with locally advanced head and neck squamous cell carcinoma.


Eligibility criteria:
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 \ 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 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