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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01950689
Recruitment Status : Active, not recruiting
First Posted : September 25, 2013
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Emmie Taylor, The Christie NHS Foundation Trust

Brief 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.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Drug: Nimorazole Radiation: Radiotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 338 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 11, 2014
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

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
Drug: Nimorazole
Radiation: Radiotherapy



Primary Outcome Measures :
  1. 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.


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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950689


Locations
Show Show 21 study locations
Sponsors and Collaborators
The Christie NHS Foundation Trust
Investigators
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Principal Investigator: David Thomson The Christie NHS Foundation Trust

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Responsible Party: Emmie Taylor, Clinical Trials Project Manager, The Christie NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01950689    
Other Study ID Numbers: CFTSp032, 11_DOG08_53
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Nimorazole
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents