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)
NCT ID: NCT01950689
Last Updated: 2021-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
338 participants
INTERVENTIONAL
2014-09-11
2021-01-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo given in parallel with radiotherapy for 6 weeks.
Radiotherapy
Nimorazole
Nimorazole given in parallel with radiotherapy for 6 weeks
Nimorazole
Radiotherapy
Interventions
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Nimorazole
Radiotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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The Christie NHS Foundation Trust
OTHER
Responsible Party
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Yamina Ainaoui
Clinical Trials Manager
Principal Investigators
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David Thomson
Role: PRINCIPAL_INVESTIGATOR
The Christie NHS Foundation Trust
Locations
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Cheltenham General Hospital
Cheltenham, Gloucestershire, United Kingdom
Clatterbridge Centre for Oncology
Bebington, Merseyside, United Kingdom
St James' Hospital
Leeds, West Yorkshire, United Kingdom
Belfast City Hospital
Belfast, , United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, , United Kingdom
Bristol Haematology and Oncology centre
Bristol, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
Velindre Cancer Centre
Cardiff, , United Kingdom
University Hospitals Coventry and Warwickshire
Coventry, , United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
The Royal Surrey County Hospital
Guildford, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
University College London Hospital
London, , United Kingdom
The Royal Marsden
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
The James Cook University Hospital
Middlesbrough, , United Kingdom
Nottingham University Hospitals
Nottingham, , United Kingdom
Weston Park Hospital
Sheffield, , United Kingdom
Singleton Hospital
Swansea, , United Kingdom
York Hospital
York, , United Kingdom
Countries
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Other Identifiers
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CFTSp032, 11_DOG08_53
Identifier Type: -
Identifier Source: org_study_id