Randomised phase II/III study comparing gemcitabine followed by gemcitabine plus concomitant radiation (50.4 Gy) versus gemcitabine alone after curative pancreaticoduodenectomy for pancreatic head cancer

European Organisation for Research and Treatment of Cancer0 个研究点目标入组 538 人开始时间: 2005年4月13日最近更新: 2012年3月19日

试验速览

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•History of pancreas head adenocarcinoma with R0 pancreaticoduodenectomy Documented histological examination of surgical margins including retroperitoneal margin. The examination must have been performed during the surgical process and by using frozen sections.
•Proper documentation related to the number of lymph nodes (< 10 lymph nodes vs = 10 lymph nodes) examined according to the UICC 1997 criteria
•Adequate liver (bilirubin < 1.5 times normal, ASAT / ALAT< 3.0 times normal) and renal
•(creatinin < 1.2 mg/dl) functions
•Presence of adequate contraception in fertile patients. Pregnant and lactating women are excluded.
•Hb> 9.0 g/dl or 5.6 mmol/L, platelets > 150000 /mm3 , WBC > 3500/mm3
•Abdominal spiral CT scan (with contrast enhancement) performed after surgery and/or a spiral CT scan performed before surgery but not older than 8 weeks at the time of randomization
•Age > or = 18
•ECOG/WHO PS < or = 2
•Complete recovery from surgery within 8 weeks
•Before patient registration/randomization, written informed consent must be given according to ICH GCP, and national/local regulations
•Before patient registration /randomization , QoL assessment should have been completed
•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

•No previous or coexistant malignant disease except BCC of the skin or carcinoma in situ of the cervix
•No previous chemotherapy or radiotherapy
•Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
•Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
•No periampullary cancer

发起方

European Organisation for Research and Treatment of Cancer