Gemcitabine plus nab-paclitaxel versus folfirinox as neoadjuvant treatment in patients with potentially resectable pancreatic carcinoma. NeoPAN Study - NeoPA

FUNDACION HOSPITAL DE MADRID0 个研究点开始时间: 2014年4月1日最近更新: 2014年4月14日

适应症

试验速览

暂无简介。

•1- Patients with cytological or anathomopathological diagnosis of pancreatic carcinoma
•2- The pancreatic tumor is resectable or borderline
•3- Older than 18 years
•4- ECOG performance status 0-1
•5- Adequate hematologic function:
•a. Neutrophils > 1.500
•b. Hemoglobin > 9
•c. Platelets > 100.000
•6- Adequate liver and kidney function:
•a. Bilirubin <= 1,5 ULN
•b. AST <= 3 ULN
•c. ALT ? 3 ULN
•d. Creatinine clearance >= 40ml/min
•7- Signed informed consent
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 14

•1.- Patients unable to complete the study procedures for geographical, psychiatric or social reasons.
•2.- Patients with some physical or psychical condition which contraindicates the study treatment
•3.- Patients with active infection or another significant or autoimmune disease.
•4.- ECOG performance status >= 2.
•5.- Chronic hepatic disease (cirrhosis, chronic hepatitis)
•6.- Another solid or hematologic concurrent tumor or previous tumors for the last 5 years. (except for basal cell carcinoma and skin epidermoid no relapsed tumors)
•7.- Pregnancy or breastfeeding period. Women of child-bearing potential and men have to use contraceptive methods or be surgically sterilized.
•8.- Patients who are taking oral anticoagulants and it cannot be replaced for subcutaneous low molecular weight heparin.
•9.- Distant pancreatic cancer metastasis.
•10.- Patients who have been previously treated for pancreatic carcinoma with radiotherapy, chemotherapy or surgical treatment different from biliary derivation or biopsy.
•11.- Impossibility or contraindication to complete any study procedure (Eco-endoscopy, NMR, MisoPET)
•12.- Prior history of neuropathy or polyneuropathy

发起方

FUNDACION HOSPITAL DE MADRID