A multi-centre randomised phase II study of induction chemotherapy followed by gemcitabine or capecitabine based chemoradiotherapy (CRT) for locally advanced non-metastatic pancreatic cancer - SCALOP

Cardiff University0 个研究点目标入组 102 人开始时间: 2008年10月9日最近更新: 2019年6月30日

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•Patients meeting the following criteria may be included in the trial:
•1. Age = 18
•2. Histologically or cytologically proven malignancy of the pancreas
•3. Locally advanced, non-metastatic, and inoperable (or operable but medically unfit for surgery) (as discussed at MDT) malignancy. The following types of interventions are allowed:
•a. palliative bypass procedure
•b. common bile duct stenting
•4. Primary pancreatic lesion =7cm in diameter as measured by a CT scan of the thorax and abdomen that has been done within 4 weeks prior to the start of induction chemotherapy
•5. WHO performance status 0-2
•6. Neutrophils = 1.5 x 109/L, platelets = 100 x 109/L and haemoglobin = 10g/dL
•7. Adequate liver function tests:
•a. Serum bilirubin <35 micro mol/L. In participants who have had a recent biliary drain and whose bilirubin is descending, a value of =50µmol/L is acceptable.
•b. AST and ALT =2.5 x ULN, alkaline phosphatase =5 x ULN
•8. Adequate renal function (GFR >50ml/min (Cockcroft & Gault)
•9. Capable of giving, and given, informed consent
•10. Potentially fertile participants should agree to use an adequate contraception method, which must be continued for 3 months after completion of chemotherapy
•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

•If any of the following criteria apply, participants cannot be included in the trial:
•1. Women who are pregnant or breast feeding
•2. Any evidence of severe uncontrolled systemic diseases including uncontrolled coronary artery disease
•3. Any participants with myocardial infarction or stroke within the last 6 months
•4. Previous malignancies in the preceding 5 years except for in situ cancer of the uterine cervix and adequately treated basal cell skin carcinoma and early stage malignancy
•5. Renal abnormalities such as polycystic kidneys or hydronephrosis or ipsilateral single kidney.
•6. Previous radiotherapy to upper abdomen
•7. Recurrent cancer following definitive pancreatic surgery
•8. Lymphoma or neuroendocrine tumours of the pancreas

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