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)

• Status: Completed
• Trial end date: 2021-01-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Christie NHS Foundation Trust
• Treatments: Cetuximab; Nimorazole

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 <=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