EUCTR2014-002382-30-GB进行中（未招募）不适用
Phase II study of neoadjuvant cisplatin and gemcitabine chemotherapy versus upfront surgery in patients with resectable proximal biliary tract cancer: - BBC
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •a)A centrally confirmed histopathological / cytological diagnosis of biliary tract carcinoma
- •b)Radiological confirmation of intrahepatic/hilar location
- •c)ECOG performance status 0, 1, or 2
- •d)Age = 18
- •e) Estimated life expectancy > 3 months
- •i.Adequate haematological function:
- •ii.Haemoglobin * 10 g/dl*
- •iii.White blood cell count (WBC) * 3.0 x 109/L
- •iv.Absolute neutrophil count (ANC) * 1.5 x 109/L
- •v.Platelet count * 100 x 109/L
- •vi.*prior transfusions for patients with low haemoglobin are allowed
- •f)Adequate liver function:
- •i.Total bilirubin =1.5 x upper limit of normal (ULN) (except for patients with known documented cases of Gilbert’s syndrome)
- •ii.ALT and/or AST ? 2.5 x ULN (If liver metastases are present, ALT or AST < 5 x ULN)
- •iii.Alkaline phosphatase ? 5 x ULN
- •g)Adequate renal function:
- •i.Serum urea < 1.5 x ULN
- •ii.Serum creatinine < 1.5 x ULN
- •iii.Calculated GFR (greater or equal to) 40 mL/min using the Cockcroft-Gault formula
- •h)No evidence of active uncontrolled infection (patients on long-term antibiotics are eligible provided signs of active infection have resolved)
- •i)Women of child-bearing potential must have a negative pregnancy test prior to study entry AND be using two methods of adequate contraception, which must be continued for 3 months after completion of treatment. Reliable methods of contraception should be used consistently and correctly. Acceptable methods include barrier methods, implants, injectables, combined oral contraceptive methods, some intra-uterine devices (IUDs), sexual abstinence or vasectomised partner.
- •j)Patient must have given written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 22
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •a)Radiological evidence suggesting inability to resect with curative intent whilst maintaining adequate vascular inflow and outflow, and sufficient future liver remnant
- •b)Radiological evidence of direct invasion into adjacent organs
- •c)Radiological evidence of extrahepatic metastatic disease
- •d)Significant haemorrhage (>30 mL bleeding/episode in previous 3 months) or haemoptysis (>5 mL fresh blood) within 4 weeks of recruitment.
- •e)Patients with history of poorly controlled hypertension with resting blood pressure >150/100 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy, or patients who are requiring maximal doses of calcium channel blockers to stabilise blood pressure
- •f)Incomplete recovery (CTCAE grade >1) from previous anti-cancer therapy side effects (except haematological toxicity – see inclusion criteria for adequate haematological function), or alopecia
- •g)Prior systemic chemotherapy for locally advanced or metastatic biliary disease is not allowed.
- •h)Unresolved biliary tree obstruction
- •i)Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- •j)Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart, unless urinary protein <1.5 g in a 24-hour period or protein/creatinine ratio < 1.5
- •k)Mean QTc with Bazetts correction >480 msec in screening ECG or history of familial long QT syndrome
- •l)Recent (<14 days) major thoracic or abdominal surgery prior to recruitment, or a surgical incision that is not fully healed
- •m)Pregnant or breast-feeding women
- •n)Known risk of the patient transmitting HIV, hepatitis B or C via infected blood
- •o)Treatment with an investigational drug within 30 days prior to recruitment
- •p)Other concomitant anti-cancer therapy (except steroids)
- •q)Patients undergoing current treatment with curative intent
- •r)History of prior malignancy that will interfere with the response evaluation (exceptions include in-situ carcinoma of the cervix treated by cone-biopsy/resection, non-metastatic basal and/or squamous cell carcinomas of the skin, any early stage (stage I) malignancy adequately resected for cure greater than 5 years previously)
- •s)Any psychiatric or other disorder likely to impact on informed consent
研究者
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