EUCTR2010-023195-22-GB进行中（未招募）1 期
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:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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