Randomised controlled open-label trial of TPF induction chemotherapy in the surgical management of locally advanced head and neck cancer(T = taxane, P = cisplatin, F = 5-fluorouracil) - TITAN - Version 6
- Conditions
- 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: 14.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2010-023195-22-GB
- Lead Sponsor
- niversity of Liverpool
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 7
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method