EUCTR2010-021658-21-IT进行中（未招募）不适用
Phase II study of preoperative TPF chemotherapy in locally advanced resectable oral cavity squamous cell cancer in order to improve the rate of pathological complete response - ND
ISTITUTO NAZIONALE PER LA CURA TUMORI0 个研究点开始时间: 2010年8月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •-Signed informed consent
- •-Males and females age > 18 years
- •-Hystologically proved primary oral cavity squamous cell cancer (tumour extending to oropharynx are accepted if oropharyngeal invasion is < 20% of the tumour size)
- •-Stage T2 (T2 stage is accepted if tumour size is 3 cm or larger).-T3, N1-N3 and T4a any N
- •-WHO performance status < 1
- •-Availability of block of Formalin Fixed Paraffin Embedded (FFPE) biopsy of the tumour
- •-Radiological imaging of the tumour with MRI pre-therapy
- •-Effective contraception for both male and female subjects if risk of conception exists
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Prior antitumor therapy for head & neck cancer (chemotherapy or biological therapy and radiotherapy)
- •-Metastatic disease
- •-Medical condition that contraindicate administration of TPF scheme, in particular:
- •a) clinically significant cardiac disease including unstable angina, acute myocardial infarction in the previous 2 years, congestive heart failure and arrhythmia requiring therapy
- •b) chronic or current infectious disease that contraindicate administration of chemotherapy causing neutropenia; known HIV, Hepatitis B or C positivity
- •c) uncontrolled renal, hepatic, neurological, cerebral, psychiatric, haematological, gastrointestinal, pulmonary, vascular or endocrine diseases that could interfere with antiblastic treatment
- •-Pre-existing peripheral neurophaty CTC grade > 1
- •-Pre-existing ototoxicity grade > 1
- •-Previous diagnosis of other cancer in the last 3 years (in situ cervical cancer or completely excised basocellular/squamocellular skin cancer are always admitted )
- •-Previous other cancer in oral cavity to less than 2 cm from existing primary
- •-Breast feeding women or women with a positive pregnancy test at Visit 0 or 1
- •-Screening laboratory values:
- •Neutrophils < 1.5 x 109/L
- •Platelets < 100 x 109/L
- •GOT or GPT > 2.5 times upper limit of normal
- •Calculated creatinine clearance < 60 mL/min according to Cockroft-Gault formula
- •Weight loss more than 20% in 3 months preceding the study
- •Technical unresectability defined as: T4b staging or N ulcerating the skin or encasing internal carotid
研究者
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