NIMRAD (A Randomised Placebo-controlled Trial of Synchronous NIMorazole Ver... | Recruiting
NIMRAD (A Randomised Placebo-contro... | Recruiting
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

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Medical Conditions
  • Head and Neck Squamous Cell Carcinoma
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
NCT01950689
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Nimorazole, Radiation : Radiotherapy

Study Arm Groups : Nimorazole, Placebo, Nimorazole

Intervention Type
See Interventions above
Primary Outcome Measures
    Locoregional Control; 12 weeks post treatment
Secondary Outcome Measures
    Overall survival; Date of death for patient, month 60.; Cancer-specific survival; follow up month 60; Disease-free survival; follow up month 60; Cumulative incidence of loco-regional failure; follow up month 60; Acute toxicity; baseline, week 1, 2, 3, 4, 5, 6, follow up month 1.5 and 3; Hypoxia signature prediction of nimorazole benefit; screening; quality of life; baseline, week 6, month 6, 12, 18, 24, 36 of follow up; Late toxicity; baseline, follow up month 6, 12, 18, 24, 36
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
470
Participant Inclusion Criteria
    Inclusion Criteria:

    - Histologically confirmed 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 chemotherapy 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, bilirubin <=2 x ULN, AST <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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Manchester
M20 4BX
Leicester Royal Infirmary
Leicester
England
LE1 5WW
Velindre Cancer Center at Velindre Hospital
Cardiff
Wales
CF14 2TL
South West Wales Cancer Institute
Sketty
Wales
SA2 8QA
GSK Investigational Site
Cambridge
CB2 0QQ
Birmingham
B15 2TH
St. James University Hospital, Department of Neurology
Leeds
LS9 7TF
Nottingham
Nottinghamshire
NG5 1PB
Novartis Investigative Site
Cheltenham
Gloucestershire
GL53 7AN
Coventry
CV2 2DX
Guildford
GU2 7XX
London
NW1 2PG
Middlesbrough
TS4 3BW
Newcastle upon Tyne
NE7 7DN
Royal Marsden Hospital - Sutton
London
England
SW3 6JJ
Cancer Care Centre at York Hospital
York
England
Y031 8HE
Bristol
BS2 8ED
Bradford
BD9 6RJ
Sheffield
S10 2SJ
Glasgow
G12 0YN
Site Reference ID/Investigator# 125695
Birkenhead
CH63 4JY
Mount Vernon Cancer Centre
HA6 2RN
Trial Contact(s)
Primary Trial Contact
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific 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)
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CFTSp032, 11_DOG08_53
Sponsor(s)
The Christie NHS Foundation Trust
Key Dates

Recruitment Start Date

May 2014

Recruitment End Date

Nov 2019

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

23 Sep 2013

Date updated in source

08 Aug 2017