IMRAD: 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: ocally advanced head and neck squamous cell carcinoma (HNSCC); MedDRA version: 14.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-002466-39-GB
• Lead Sponsor: The Christie NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-08
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

1. 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)
2. Stage T3/T4 N0; any node +ve case including T1 node +ve; T2N0 base of tongue/hypopharynx
3. Patients suitable for definitive radiotherapy. Block dissections may be performed pre-RT for N2/N3 disease
4. WHO status 0-2
5. Patient fit and able to undergo RT with nimorazole and be expected to complete treatment
6. Absence of another disease or previous malignancy which is likely to interfere with the treatment or assessment of response.
7. No evidence of distant metastases (M0)
8. Unable to tolerate/ unlikely to benefit from platinum chemotherapy or monoclonal antibody therapy
9. 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).
10. Greater than 18 years of age; no upper age limit
11. Available for follow up within the United Kingdom
12. Adequate renal and liver function - absolute neutrophil count = 1.5 x 109/L, creatinine = 2 x ULN, platelets > 100 x 109/L, bilirubin = 2 x ULN, AST < 3 x ULN
13. The capacity to understand the patient information sheet and the ability to provide written informed consent
14. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 118
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 352

Exclusion Criteria

1. Patients with T1N0 tumours or those within the nasopharynx, nasal cavity or sinus, oral cavity; T2N0 larynx and tonsil; unknown primary cancer
2. Any prior chemotherapy in the last 6 months or RT within the planned radiation field
3. Presence of any life threatening illness such as unstable angina or severe chronic obstructive pulmonary disease
4. Mental disability or patient otherwise unable to give informed consent and/or complete patient questionnaires
5. Hb <100 g/l (patients with anaemia may be transfused to bring Hb levels to >100 g/l.] within 1 week of treatment start)
6. Peripheral neuropathy as assessed clinically (CTCAE = Grade 2)
7. Use of any investigational drug within 30 days prior to screening
8. Severe and/or uncontrolled medical disease
9. Any malabsorption syndrome (i.e. partial gastrectomy, small bowel resection, Crohn’s disease or ulcerative colitis)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified