EUCTR2013-001949-13-NO进行中（未招募）不适用
An International Multicentre Open Label Randomised Phase II Advanced Anal Cancer Trial Comparing Cisplatin plus 5-fluorouracil versus Carboplatin plus Weekly Paclitaxel in Patients with Inoperable Locally Recurrent or Metastatic Disease - InterAACT A Multicentre Randomised Phase II Advanced Anal Cancer Trial
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
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.Histologically or cytologically verified, uni-dimensionally measurable, inoperable, locally recurrent or metastatic squamous cell carcinoma of the anus.
- •2.Age =18 years.
- •3.ECOG PS =2.
- •4.Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1.
- •5.Previous definitive chemo-radiation is permitted for early stage squamous cell carcinoma of the anus.
- •6.HIV+ patients will be considered eligible with a CD4 count of =200.
- •7.Adequate cardiac and respiratory function; absolute neutrophil count (ANC) =1.5x109/l; white blood cell (WBC) count =3x109/l; platelets =100x109/l; haemoglobin (Hb) =9g/dl; creatinine clearance =50ml/minute; serum bilirubin =1.5x upper limit of normal (ULN); alanine transaminase (ALT)/aspartate transaminase (AST) =2.5x ULN; alkaline phosphatase (ALP) =3x ULN.
- •8.Life expectancy of at least 3 months.
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Tumours of adenocarcinoma, melanoma, small cell and basal cell histology are
- •2.Previous chemotherapy, radiotherapy or other investigational drug for surgically unresectable locally recurrent or advanced squamous cell carcinoma of the anus.
- •3.Current or recent (within 30 days of first study dosing) treatment with another investigational drug or participation in another investigational study.
- •4.Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease.
- •5.Surgery or palliative radiotherapy within 28 days of randomisation.
- •6.Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease, uncontrolled cardiac arrhythmia, or myocardial infarction within the last 6 months). Any history of clinically significant cardiac failure.
- •7.History of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan.
- •8.Lack of physical integrity of the gastro-intestinal tract, malabsorption syndrome (naso-gastric or jejunostomy feeding tube is permitted).
- •9.Acute hepatitis C and/or chronic active hepatitis B infection.
- •10.Serious active infection requiring i.v. antibiotics at enrolment.
- •11.Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
- •12.Other clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this trial.
- •13.Known hypersensitivity to any of the study drugs or excipients.
- •14.Pregnant or lactating females.
研究者
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