Randomised controlled open-label trial of TPF (taxane cisplatin 5-fluorouracil) induction chemotherapy in the surgical management of locally advanced head and neck cancer

Aintree University Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 7 人开始时间: 2011年8月10日最近更新: 2020年7月6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. Tumour (T) stage in one of the following site categories:
•3.1. Lip/ Oral cavity: stage T3 or T4a (and >=4cm in largest dimension)
•3.2. Paranasal /nasal: stage T4a
•3.3. Larynx: stage T4a
•3.4. Hypopharynx: stage T3 or T4a
•3.5. Cervical oesophagus: stage T3 or T4a
•3.6. Oropharynx: stage T3 or T4a and HPV-ve
•4. Any lymph node (N) stage
•5. No metastases (M0)
•6. An multidisciplinary team (MDT) decision to offer surgery as primary modality of treatment
•7. World Health Organisation (WHO) performance status 0 or 1
•8. Resectable by conventional criteria in both primary site and any cervical lymph node involvement
•9. Male or female paticipants
•10. Lower age limit: 18 years

•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 (note: positron emission tomography - computed tomography [PET-CT] is necessary investigation for all patients entering trial - as such additional CT chest will usually not be required to exclude pulmonary or hepatic metastases)
•4. Nasopharynx site
•5. Human papillomavirus (HPV) - positive oropharyngeal cancer (OPC)
•6. Pregnancy or lactation
•7. Patients with haemoglobin of <10g/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 impairment (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 (For the purpose of the study, significant renal impairment is classed as GFR <50ml/min>. However, sites may use their local policy if a higher threshold is dictated.)
•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

Aintree University Hospitals NHS Foundation Trust (UK)