Head and Neck Squamous Cell CarcinomaPhase 3NIMRADNCT01950689
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)
A Phase 3 study testing Nimorazole and Radiotherapy in people with Head and Neck Squamous Cell Carcinoma, run by The Christie NHS Foundation Trust at 21 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Nimorazole and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 338 participants
- Where
- 21 sitesUnited Kingdom
- Study dates
- 11 Sep 2014to 7 Jan 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United Kingdom21 sites
Clatterbridge Centre for Oncology
Bebington, Merseyside, CH63 4JY
Belfast City Hospital
Belfast, BT9 7AB
Queen Elizabeth Hospital
Birmingham, B15 2TH
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, BD9 6RJ
Bristol Haematology and Oncology centre
Bristol, BS2 8ED
Addenbrookes Hospital
Cambridge, CB2 0QQ
Velindre Cancer Centre
Cardiff, CF14 2TL
Cheltenham General Hospital
Cheltenham, Gloucestershire, GL53 7AN
University Hospitals Coventry and Warwickshire
Coventry, CV2 2DX
The Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
The Royal Surrey County Hospital
Guildford, GU2 7XX
St James' Hospital
Leeds, West Yorkshire, LS9 7TF
Leicester Royal Infirmary
Leicester, LE1 5WW
University College London Hospital
London, NW1 2PG
The Royal Marsden
London, SW3 6JJ
The Christie NHS Foundation Trust
Manchester, M20 4BX
The James Cook University Hospital
Middlesbrough, TS4 3BW
Nottingham University Hospitals
Nottingham, NG5 1PB
Weston Park Hospital
Sheffield, S10 2SJ
Singleton Hospital
Swansea, SA2 8QA
York Hospital
York, Y031 8HE
About this study
Official title: 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.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Nimorazole, Radiotherapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimorazoleDrug
RadiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo given in parallel with radiotherapy for 6 weeks. Receives: Radiation: Radiotherapy |
| Nimorazole | Experimental | Nimorazole given in parallel with radiotherapy for 6 weeks Receives: Drug: Nimorazole; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional Control in patients with more hypoxic tumours (the enriched population)
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.
Measured: 12 weeks post treatment
Secondary outcomes (8)
Overall survival (enriched sub-group)
Measured: Date of death for patient, month 60.
Cancer-specific survival (enriched sub-group)
Measured: follow up month 60
Disease-free survival (enriched sub-group)
Measured: follow up month 60
Cumulative incidence of loco-regional failure
Measured: follow up month 60
Acute toxicity (all patients)
Measured: baseline, week 1, 2, 3, 4, 5, 6, follow up month 1.5 and 3
Hypoxia signature prediction of nimorazole benefit (all patients)
Measured: screening
Quality of life (enriched sub-group)
Measured: baseline, week 6, month 6, 12, 18, 24, 36 of follow up
Late toxicity (all patients)
Measured: baseline, follow up month 6, 12, 18, 24, 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study start11 Sep 2014
- Primary completion7 Jan 2021
- Study completion7 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yamina Ainaoui, The Christie NHS Foundation Trust
- Investigators
- David Thomson, Principal investigator, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950689
- Sponsor's protocol ID
- CFTSp032, 11_DOG08_53
- Acronym
- NIMRAD
- Status last verified
- Oct 2021
- First submitted
- 23 Sep 2013
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thomson DJ, Slevin NJ, Baines H, Betts G, Bolton S, Evans M, Garcez K, Irlam J, Lee L, Melillo N, Mistry H, More E, Nutting C, Price JM, Schipani S, Sen M, Yang H, West CM; NIMRAD Trial Group. Randomized Phase 3 Trial of the Hypoxia Modifier Nimorazole Added to Radiation Therapy With Benefit Assessed in Hypoxic Head and Neck Cancers Determined Using a Gene Signature (NIMRAD). Int J Radiat Oncol Biol Phys. 2024 Jul 1;119(3):771-782. doi: 10.1016/j.ijrobp.2023.11.055. Epub 2023 Dec 9.
PubMed 38072326
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01950689
- Acronym / sponsor ID
- NIMRAD / CFTSp032, 11_DOG08_53
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- 11 Sep 2014 (actual)
- Primary completion
- 7 Jan 2021 (actual)
- Study completion
- 7 Jan 2021 (actual)
- First posted
- 25 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Radiation: RadiotherapyPlacebo given in parallel with radiotherapy for 6 weeks. |
| Nimorazole | Experimental | Drug: Nimorazole, Radiation: RadiotherapyNimorazole given in parallel with radiotherapy for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nimorazole | Drug | Nimorazole |
| Radiotherapy | Radiation | Nimorazole, Placebo |
Primary outcome
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.
8 secondary outcomes
Overall survival (enriched sub-group)
Time frame: Date of death for patient, month 60.
Cancer-specific survival (enriched sub-group)
Time frame: follow up month 60
Disease-free survival (enriched sub-group)
Time frame: follow up month 60
Cumulative incidence of loco-regional failure
Time frame: 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
Hypoxia signature prediction of nimorazole benefit (all patients)
Time frame: screening
Quality of life (enriched sub-group)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Derived from this study: PubMed 38072326Thomson DJ, Slevin NJ, Baines H, Betts G, Bolton S, Evans M, Garcez K, Irlam J, Lee L, Melillo N, Mistry H, More E, Nutting C, Price JM, Schipani S, Sen M, Yang H, West CM; NIMRAD Trial Group. Randomized Phase 3 Trial of the Hypoxia Modifier Nimorazole Added to Radiation Therapy With Benefit Assessed in Hypoxic Head and Neck Cancers Determined Using a Gene Signature (NIMRAD). Int J Radiat Oncol Biol Phys. 2024 Jul 1;119(3):771-782. doi: 10.1016/j.ijrobp.2023.11.055. Epub 2023 Dec 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Thomson principal investigator
The Christie NHS Foundation Trust
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nimorazole and Radiotherapy in people with Head and Neck Squamous Cell Carcinoma, run by The Christie NHS Foundation Trust at 21 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional Control in patients with more hypoxic tumours (the enriched population) (time frame: 12 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01950689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.