Head and Neck Squamous Cell Carcinoma, in any of the following sites: - Lip / Oral Cavity - Paranasal / Nasal - Larynx - Hypopharynx - Cervical Osephagus - Oropharynx (HPV - ve) MedDRA version: 14.1 Level: PT Classification code 10067821 Term: Head and neck cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Docetaxel
Product Name: Docetaxel
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Docetaxel
CAS Number: 148408-66-6
Concentration unit: mg milligram(s)
Conc
Sponsors
University of Liverpool
Aintree University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >18 years 2. Histopathological diagnosis of head and neck squamous cell carcinoma 3. T stage in one of the following site categories: a. Lip/ Oral cavity: stage T3 or T4a (and >=4cm in largest dimension) b. Paranasal /nasal: stage T4a c. Larynx: stage T4a d. Hypopharynx: stage T3 or T4a e. Cervical oesophagus: stage T3 or T4a f. Oropharynx: stage T3 or T4a and HPV-ve 4. Any N stage 5. M0 6. An MDT decision to offer surgery as primary modality of treatment 7. WHO performance status 0 or 1 8. Resectable by conventional criteria in both primary site and any cervical lymph node involvement 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 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Those tumours staged to T4a on the basis of early mandibular invasion alone, i.e. <4cm in the maximum dimension 2. Unresectable disease on clinical staging (including imaging) of primary tumour or cervical metastasis. 3. Distant metastases (PET_CT or other conventional imaging methods should be used to exclude pulmonary or hepatic metastases (please See Appendix F). 4. Nasopharynx site 5. HPV +ve Oropharyngeal Site 6. Pregnancy or lactation 7. Patients with haemoglobin of <10.0g/dl 8. Patients with neutrophil counts of <1.5 x 109/l. 9. Patients with thrombocyte counts of <100 x 109/l. 10.Patients with significant hepatic (Bilirubin <1.5x upper limit of normal range; ALT <2.5x upper limit of normal range; ALP <5x upper limit of normal range) 11.Patients with significant renal impairment (GFR <50ml/min). 12.Patients who lack mental capacity to give informed consent. 13.Patients whose co morbidities or concomitant medications otherwise preclude TPF chemotherapy. 14.All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim is to determine whether enough patients agree to be randomised in this feasibility study so that the full phase III would be able to recruit the target sample size within 4 more years. This will be determined by setting up at least 4 centres, each of which should recruit an average of 1 patient per month during a 12 month period. ;Secondary Objective: The secondary aims are to compare how many patients were screened to how many patients were randomised. Also, we will be looking at the percentage of patients in the TPF arm who complete their full course of treatment, including surgery and PORT. ;Primary end point(s): Feasibility of recruitment into the TITAN trial (specifically the number of patients recruited from at least 4 centres during a 12 month period). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): I. Randomisation: Screening Ratio II. The percentage of patients in the TPF arm who complete the full course of treatment (including post-operative radiotherapy / chemoradiotherapy) ;Timepoint(s) of evaluation of this end point: Analysis for the secondary outcomes will be carried out using simple summary statistics and shall be recorded along with the appropriate 95% confidence intervals. | — |
Countries
United Kingdom
Outcome results
None listed