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

niversity of Liverpool0 个研究点目标入组 7 人开始时间: 2011年4月15日最近更新: 2020年7月27日

适应症

试验速览

暂无简介。

•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
•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.

发起方

niversity of Liverpool