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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)
Conditions
Head and Neck Squamous Cell Carcinoma
Conditions: official terms
Carcinoma - Carcinoma, Squamous Cell - Head and Neck Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention
Name: Nimorazole
Type: Drug
Name: Radiotherapy
Type: Radiation
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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/hypopharnx
- Pateints 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 metasteses (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)
- Greater than 18 years of age; no upper age limit
- written informed consent
- available for follow up within the United Kingdom
- Adequate renal and liver function - absolute neurophil 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)
- 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)
- 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/hypopharnx
- Pateints 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 metasteses (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)
- Greater than 18 years of age; no upper age limit
- written informed consent
- available for follow up within the United Kingdom
- Adequate renal and liver function - absolute neurophil 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)
- 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)
Locations
Cheltenham general hospital
Cheltenham, Gloucestershire, United Kingdom
Clatterbridge centre for oncology
Status: Recruiting
Bebington, Merseyside, United Kingdom
St James' Hospital
Status: Recruiting
Leeds, West Yorkshire, United Kingdom
Belfast City Hospital
Status: Recruiting
Belfast, United Kingdom
Queen Elizabeth hospital
Status: Not yet recruiting
Birmingham, United Kingdom
Bristol Haematology and Oncology centre
Status: Recruiting
Bristol, United Kingdom
Addenbrookes Hospital
Status: Recruiting
Cambridge, United Kingdom
Velindre Cancer Centre
Status: Recruiting
Cardiff, United Kingdom
The Beatson west of scotland cancer centre
Status: Not yet recruiting
Glasgow, United Kingdom
The Royal Surrey County Hospital
Status: Not yet recruiting
Guildford, United Kingdom
The Royal Marsden
Status: Not yet recruiting
London, United Kingdom
The Christie NHS Foundation Trust
Status: Recruiting
Manchester, United Kingdom
Mount Vernon
Status: Recruiting
Middlesex, United Kingdom
Freeman hospital
Status: Not yet recruiting
Newcastle, United Kingdom
Nottingham University hospitals
Status: Not yet recruiting
Nottingham, United Kingdom
Weston Park Hospital
Status: Not yet recruiting
Sheffield, United Kingdom
Singleton Hospital
Status: Recruiting
Swansea, United Kingdom
Status: Not yet recruiting
Start Date
May 2014
Completion Date
June 2020
Sponsors
Christie Hospital NHS Foundation Trust
Source
Christie Hospital NHS Foundation Trust
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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