EUCTR2006-001742-13-GB进行中（未招募）1 期
ocally Advanced Pancreatic Cancer: Phase II study of cetuximab and 3-D conformal image-guided radiotherapy (PACER Study) - PACER Study
Christie Hospital NHS Trust0 个研究点目标入组 44 人开始时间: 2006年9月29日最近更新:
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
- 44
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
入选标准
- •Histopathological or cytological diagnosis of inoperable, non-metastatic pancreatic adenocarcinoma
- •Karnofsky Performance (KP) Status 100 - 60
- •Age = 18 and estimated life expectancy > 3 months
- •Adequate haematological function: Haemoglobin = 10g/dl; WBC = 3.0 x 109/l; ANC = 1.5 x 109/l; platelet count = 100,000/mm3 (prior transfusions for patients with low haemoglobin allowed)
- •Adequate liver function: total bilirubin = 1.5 x ULN; ALT & AST = 1.5 x ULN; ALP = 4 x ULN
- •Adequate renal function with serum urea & creatinine = 1.5 x ULN and a calculated creatinine clearance (Appendix 2) of > 50 ml/min. If the calculated creatinine clearance is marginally less than > 50 ml/min, an isotopic EDTA clearance test will be performed to confirm the creatinine clearance.
- •Adequate biliary drainage with no evidence of active uncontrolled infection (patients on prophylactic antibiotics are eligible)
- •Women of child-bearing potential should have a negative pregnancy test prior to study entry AND be suing an adequate contraception method, which must be continued for 3 months after completion of chemotherapy
- •Capable of giving informed consent
- •Following types of interventions are allowed:
- •- non-curative operation (i.e. R2 resection with macroscopic residual disease evident on CT scan or palliative bypass procedure)
- •- stent insertion in the common bile duct
- •KP Status 60–100
- •Patients able to tolerate 3 PET scans
- •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
- •Patients with neuroendocrine tumours or lymphoma of the pancreas
- •Incomplete recovery from previous surgery or unresolved biliary tract obstruction
- •Patients with metastatic disease
- •Patients with extensive disease unable to be covered in a radically treatable radiotherapy volume
- •Previous radiotherapy within treatment field
- •Relative contraindication to radiotherapy
- •Previous administration of EGF monoclonal antibodies, EGFR signal transduction inhibitors or EGFR targeted therapy
- •History of prior malignancy that will interfere with the response evaluation (except cervical carcinoma in-situ treated by cone-biopsy/resection, non-metastatic basal &/or squamous cell carcinomas of the skin, any early stage (stage I) malignancy adequately resected for cure greater than 5 years previously)
- •Any evidence of severe uncontrolled systemic diseases or laboratory finding that in the view of investigator makes it undesirable for the patient to participate in the trial
- •Any disorder likely to impact compliance with the protocol
- •Pregnancy or breast feeding
- •Patients unable to give informed consent
- •Patients with other serious co-morbid conditions and/or serious uncontrolled infections
- •Sexually active males or females of reproductive capacity who are not employing adequate contraception
- •Patients whose sociological, psychological, familial and geographical conditions do not permit compliance with the protocol
- •Patients with a haemoglobin level < 10 g / dl
- •Patients must not have any bleeding disorder nor be on anticoagulants
研究者
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