Induction Chemotherapy with Gemcitabine-Oxaliplatin GEM-OXA followed by concomitant weekly Gemcitabine plus Radiotherapy GEM/RT in Locally Advanced, Unresectable Pancreatic Cancer A Phase II Study - gemoxa followed by gem-rt

ISTITUTI FISIOTERAPICI OSPITALIERI0 个研究点目标入组 56 人开始时间: 2006年3月15日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Histologically/cytologically proven adenocarcinoma of the pancreas - Locally advanced, non resectable, non metastatic disease - Uni-dimensionally measurable disease - No previous chemo or radiotherapy - ECOG Performance Status PS 2 and Karnofsky index 60 Appendix I - Age between 18 and 75 years old - Life expectancy 12 weeks - No known CNS metastases - Neutrophils 1500/mm3 - Platelets 100 000/mm3 - Alkaline phosphatase 5 x Upper Normal Limit UNL and Bilirubin 1.5 x UNL jaundice present at diagnosis must be controlled by either biliary stenting or percutaneous drainage before treatment start - Creatinine 1.5 x UNL - No sensory neuropathy at inclusion - Pain and jaundice controlled before inclusion - Signed, written informed consent - Pain control by well conducted antalgic treatments
•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

•- Pregnant or breast feeding women - Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia - Uncontrolled or persistant hypercalcemia - History of significant neurologic or psychiatric disorders - Vater ampulomas and biliary tract adenocarcinomas - Other non cured- malignancies

发起方

ISTITUTI FISIOTERAPICI OSPITALIERI