Gemcitabine plus nab-paclitaxel versus folfirinox in patients with potentially resectable pancreatic carcinoma.

Conditions: Potentially resectable pancreatic cancer
MedDRA version: 16.1Level: LLTClassification code 10033608Term: Pancreatic cancer resectableSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-005087-25-ES

Lead Sponsor: FUNDACION HOSPITAL DE MADRID

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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