EUCTR2013-004968-56-GB进行中（未招募）1 期
A multi-centre randomised study of induction chemotherapy followed by capecitabine (+/-nelfinavir) with high or standard dose radiotherapy for locally advanced non-metastatic pancreatic cancer - Systemic therapy and Chemoradiation in Advanced LOcalised Pancreatic cancer – 2
niversity of Oxford Clinical Trials & Research Governance0 个研究点目标入组 196 人开始时间: 2015年10月30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
- 196
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.Aged 18 years or over
- •2.Histologically or cytologically proven carcinoma of the pancreas
- •3.Locally advanced, non-metastatic inoperable disease as per NCCN criteria. The following types of interventions are allowed:
- •a.Palliative bypass procedure
- •b.Common bile duct stenting
- •4.Primary pancreatic lesion 6cm or less in diameter (taken from scan results)
- •5.WHO PS 0-1
- •6.Adequate haematological function: neutrophils =1.5 x 109/L and platelets =100 x 109/L
- •7.Adequate liver function tests:
- •a.Serum bilirubin =1.5 x ULN. In participants who have had a recent biliary drain and whose bilirubin is descending, a value of =3 x ULN is acceptable, however treatment should not start unless Bilirubin is =1.5 x ULN.
- •b.AST and/or ALT = 3 x ULN
- •8. Adequate renal function: GFR = 40 mL/min using a validated creatinine clearance calculation (e.g. Cockcroft-Gault (Appendix 3) or, Wright formula, or as per local standard).
- •9.Written informed consent obtained
- •10.Women of child-bearing potential must have negative serum or urine pregnancy test within 14 days prior to registration, must agree to use a highly effective contraception method during GEMABX treatment and for 6 months after last administration of GEMABX and to use an acceptable contraception method during chemoradiotherapy and for 6 months after completion of all treatment.
- •11. Male patients must be surgically sterile or must agree to use a condom during GEMABX treatment and for 6 months after last administration of GEMABX, and to use a condom during chemoradiotherapy and for three months after completion of chemoradiotherapy or whichever date comes last.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 146
排除标准
- •If any of the following criteria apply, patients cannot be included in the trial:
- •1.Primary resectable cancer of the pancreas.
- •2.Distant metastases
- •3.Pregnant or breast-feeding patients.
- •4.Any evidence of severe uncontrolled systemic diseases including uncontrolled coronary artery disease, myocardial infarction or stroke within the last six months, any major systemic or psychiatric co-morbidities or any other considerations that the PI judges might impact on patient safety or protocol compliance and achievement of the study aims.
- •5.Previous malignancies in the preceding three years except for:
- •a.In situ cancer of the uterine cervix
- •b.Adequately treated basal cell skin carcinoma
- •c.Adequately treated early stage non-pancreatic malignancy in complete remission for at least three years
- •6.Renal abnormalities including adult polycystic kidney disease or hydronephrosis or ipsilateral single kidney (ie functioning right kidney for head tumours; left kidney for tail tumours)that may preclude upper abdominal radiotherapy without damaging functional kidneys
- •7.Previous RT to upper abdomen
- •8.Recurrent cancer following definitive pancreatic surgery
- •9.Lymphoma or neuroendocrine tumours of the pancreas
- •10.Known haemophilia A and B, chronic hepatitis type B or C.
- •11.Other experimental treatment six weeks or less prior to registration into this study (including chemotherapy and immunotherapy).
- •12.Known hypersensitivity to any of the IMPs or any of their excipients e.g. hypersensitivity to products containing albumin
- •13.Known dihydropyrimidine dehydrogenase (DPD) deficiency
- •14.Known galactose intolerance, Lapp-lactose deficiency or glucose-galactose malabsorption
- •15.History of severe unexpected reaction to fluoropyrimidine therapies
- •16.If the following concomitant medications cannot be discontinued temporarily during the CRT phase then the patients cannot enter the trial as they interact with Capecitabine:
- •a.Sorivudine and analogues e.g. brivudine
- •b.Methotrexate.
- •c.Allopurinol and dipyridamole
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