ISRCTN52780546已完成3 期

Oxaliplatin/folinic acid/5-fluorouracil (24-hour) (OFF) plus best supportive care versus best supportive care alone (BSC) in second-line therapy of gemcitabine-refractory advanced pancreatic cancer

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)0 个研究点目标入组 46 人开始时间: 2007年12月21日最近更新: 2021年4月19日

适应症

试验速览

•1. Histologically or cytologically proven advanced pancreatic cancer after confirmed failure of treatment with gemcitabine
•2. No more than three weeks between confirmed failure of treatment with gemcitabine and start of second-line therapy
•3. Karnofsky performance status greater than 70%
•4. Measurable disease of more than 15 x 15 mm per computed tomography (CT) or magnetic resonance (MR) scan
•5. Leucocytes greater than 3.5 x 10^9/L, platelets greater than 100 x 10^9/L
•6. Written informed consent
•7. Age of 18 years or more
•8. Sufficient contraception up to three months after the end of therapy

•1. Active infection (as decided by physician)
•2. Pregnant or breastfeeding women
•3. Psychiatric disorders
•4. Heavy disorders, contradictory with study (as decided by physician)
•5. Heavy complications of the tumour, requiring an acute therapy
•6. Heavy cardiac disorders
•7. Peripheral, sensory and/or motor neuropathy (greater than II° - grade of sensoric/motoric toxicity regarding National Cancer Institute [NCI] criteria)
•8. Hyperesthesia against study medication or related drugs
•9. Patients with renal failure (creatinine clearance less than 30 ml/min)

发起方

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)