A study to evaluate the efficacy of oxaliplatin- or gemcitabine-based chemotherapy after allocation by standard criteria or by genetic markers in patients with resected pancreatic carcinoma

Korábbi kezelés

• Any other concurrent antineoplastic treatment including irradiation.
• Macroscopic incomplete tumour removal (R2 resection).

Más betegség

• Solid pseudopapillary neoplasm, neuroendocrine neoplasm, pancreatoblastoma, bile duct cancer, and ampullary cancer.
• History of hypersensitivity or other known contraindication to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
• Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix or bladder, or low/intermediate risk prostate cancer (Gleason score ≤7) with normal PSA levels.
• Distant metastases, including ascites or malignant pleural effusion.
• Cardiomyopathy or congestive heart failure, NYHA III-IV or coronary heart disease symptoms.
• Major comorbidity that may preclude the delivery of treatment or known active infection (HIV or chronic hepatitis B or C) or uncontrolled diabetes.
• Pre-existing neuropathy, Gilbert's disease or known genotype UGT1A1*28 /*28.
• Inflammatory disease of the colon or rectum, or intestinal obstruction, or severe postoperative uncontrolled diarrhoea.

Egyéb

• Pregnancy and lactation.
• Participation in other clinical trials or observation period of competing trials, respectively.
• Post-operative CA 19-9 >180 U / ml before randomization on study.
• Known severe dihydropyrimidine dehydrogenase (DPD) deficiency (activity score <1). There are clear guidelines for dose reductions for patients with a score of 1 and 1,5 (2 is normal activity).

• Histologically proven pancreatic ductal adenocarcinoma including variants, and pancreatic acinar cell carcinoma.
• Creatinine clearance ≥ 50 mL/min.
• Patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use highly effective methods of contraception during the study and for 6 months after the last study treatment intake for women and 6 months for men.
• Intended interval since surgery between 21 and 84 days at date of randomization.
• Public or private health insurance cover.
• Ability of subject to understand character and individual consequences of the clinical trial.
• Not legally incapacitated.
• Written informed consent must be available before enrolment in the trial.
• Patient had provided tumour tissue at resection for RNAseq
• Macroscopically complete resection (R0 or R1 resection).
• Female and male Patients aged from 18 to 79 years.
• WHO performance status 0-1.
• No prior radiotherapy and no previous chemotherapy for pancreatic cancer.
• Full recovery from surgery and patient able to receive chemotherapy: adequate oral nutrition of ≥ 1500 calories per day and free of significant nausea and vomiting.
• Adequate hematologic function: Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3, platelets ≥ 100,000 cells/mm3 and haemoglobin ≥ 8 g/L (transfusion permitted).
• Serum total bilirubin ≤ 1.5 times the institutional upper limit of normal.