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) (NIMRAD)

October 11, 2021 updated by: Yamina Ainaoui, The Christie NHS Foundation Trust

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

338

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Belfast City Hospital
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Teaching Hospitals NHS Foundation Trust
      • Bristol, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrookes Hospital
      • Cardiff, United Kingdom, CF14 2TL
        • Velindre Cancer Centre
      • Coventry, United Kingdom, CV2 2DX
        • University Hospitals Coventry and Warwickshire
      • Glasgow, United Kingdom, G12 0YN
        • The Beatson West of Scotland Cancer Centre
      • Guildford, United Kingdom, GU2 7XX
        • The Royal Surrey County Hospital
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • London, United Kingdom, NW1 2PG
        • University College London Hospital
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust
      • Middlesborough, United Kingdom, TS4 3BW
        • The James Cook University Hospital
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospitals
      • Sheffield, United Kingdom, S10 2SJ
        • Weston Park Hospital
      • Swansea, United Kingdom, SA2 8QA
        • Singleton Hospital
      • York, United Kingdom, Y031 8HE
        • York Hospital
    • Gloucestershire
      • Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
        • Cheltenham General Hospital
    • Merseyside
      • Bebington, Merseyside, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • St James' Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo given in parallel with radiotherapy for 6 weeks.
Radiation: Radiotherapy
Experimental: Nimorazole
Nimorazole given in parallel with radiotherapy for 6 weeks
Radiation: Radiotherapy
Drug: Nimorazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Locoregional Control in patients with more hypoxic tumours (the enriched population)
Time Frame: 12 weeks post treatment
To examine whether patients with locally advanced head and neck squamous cell carcinoma unsuitable for either cisplatin chemotherapy or monoclonal antibody therapy benefit from the addition of nimorazole to standard definitive radiotherapy in terms of increased locoregional control without additional serious toxicity.
12 weeks post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (enriched sub-group)
Time Frame: Date of death for patient, month 60.
Date of death for patient, month 60.
Cancer-specific survival (enriched sub-group)
Time Frame: follow up month 60
follow up month 60
Disease-free survival (enriched sub-group)
Time Frame: follow up month 60
follow up month 60
Cumulative incidence of loco-regional failure
Time Frame: follow up month 60
follow up month 60
Acute toxicity (all patients)
Time Frame: baseline, week 1, 2, 3, 4, 5, 6, follow up month 1.5 and 3
baseline, week 1, 2, 3, 4, 5, 6, follow up month 1.5 and 3
Hypoxia signature prediction of nimorazole benefit (all patients)
Time Frame: screening
screening
Quality of life (enriched sub-group)
Time Frame: baseline, week 6, month 6, 12, 18, 24, 36 of follow up
baseline, week 6, month 6, 12, 18, 24, 36 of follow up
Late toxicity (all patients)
Time Frame: baseline, follow up month 6, 12, 18, 24, 36
baseline, follow up month 6, 12, 18, 24, 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Christie NHS Foundation Trust

Investigators

  • Principal Investigator: David Thomson, The Christie NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2014

Primary Completion (Actual)

January 7, 2021

Study Completion (Actual)

January 7, 2021

Study Registration Dates

First Submitted

September 23, 2013

First Submitted That Met QC Criteria

September 23, 2013

First Posted (Estimate)

September 25, 2013

Study Record Updates

Last Update Posted (Actual)

October 19, 2021

Last Update Submitted That Met QC Criteria

October 11, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTSp032, 11_DOG08_53

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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