Klinische Studie
An open labelled phase III adjuvant trial of disease-free survival in patients with resected pan-creatic ductal adenocarcinoma randomized to allocation of oxaliplatin- or gemcitabine-based chemotherapy by standard clinical criteria or by a transcriptomic treatment specific stratifica-tion signature)(ESPAC-6)An open labelled phase III trial of survival in patients with resected pancreatic ductal adenocarcinoma randomized to allocation of oxaliplatin- or gemcitabine-based chemotherapy
Krankheitsentität(en)
Bauchspeicheldrüse (Pankreas)
StudientypInterventionsstudiePhase III
StudientypInterventionsstudiePhase III
Wesentliche Einschlusskriterien1. Histologically proven pancreatic ductal adenocarcinoma including variants, and acinar cell carcinoma.
2. Patient had provided tumour tissue at resection for RNAseq
3. Macroscopically complete resection (R0 or R1 resection).
4. Female and male Patients aged from 18 to 79 years.
5. WHO performance status 0-1.
6. No prior radiotherapy and no previous chemotherapy.
7. 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
8. Adequate hematologic function: Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3, platelets ≥ 100,000 cells/mm3 and haemoglobin ≥ 8 g/L (transfusion permitted).
9. Serum total bilirubin ≤ 1.5 times the institutional upper limit of normal.
10. Creatinine clearance ≥ 50 mL/min.
11. 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 4 months after the last study treatment intake for women and 6 months for men.
12. Intended
Wesentliche Ausschlusskriterien1. Other types of non-ductal tumour of the pancreas, including endocrine tumours or acinar cell adenocarcinoma, cystadenocarcinoma, bile duct carcinoma, and ampullary carcinoma.
2. Distant metastases, including ascites or malignant pleural effusion.
3. Macroscopic incomplete tumour removal (R2 resection).
4. CA 19-9> 180 U / ml within 21 days of registration on study.
5. Cardiomyopathy or congestive heart failure, NYHA III-IV or coronary heart disease symptoms.
6. Major comorbidity that may preclude the delivery of treatment or known active infection (HIV or chronic hepatitis B or C) or uncontrolled diabetes.
7. Pre-existing neuropathy, Gilbert's disease or known genotype UGT1A1*28 /*28.
8. Inflammatory disease of the colon or rectum, or intestinal obstruction, or severe postoperative uncontrolled diarrhoea.
9. Known Dihydropyrimidine dehydrogenase (DPD) deficiency
10. Pregnancy and lactation.
11. Participation in other clinical trials or observation period of competing trials, respectively.
12. 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.
13. 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.
14. Any other concurrent antineoplastic treatment including irradiation
No subject will be allowed to enrol in this trial more than once.
4.6 Enrolment and Assignment of Identification Codes
Every patient planned for surgery for adenocarcinoma of the pancreas and who would be potentially eligible for randomization will be informed and may give consent for pre-screening (i.e. use and analysis of tumour material/blood for RNAseq at DKFZ, Heidelberg). Patients having given written informed consent for the pre-screening will be tracked in a pre-screening log at the site and obtain a unique, consecutive pre-screening number which is used for identification during pre-screening for pseudonymized identification.
The Site will inform IKF about pre-screened patients using a specific form and IKF causes the shipment of a prepared sample kit with dry ice by the NCT to the site. After surgery, site sends sample kits to HD NCT SPL where the samples are stored. When the patient is discharged from hospital, site will send blinded reports of local pathology to IKF along with a short form containing specific information. If patients confirmed to have ductal adenocarcinoma, no stage IV, no metastases, no R2 resection, IKF will trigger sample processing at HD NCT SPL.
Based on
Statusin Vorbereitung
Ansprechpartner & KontaktUniversitätsklinikum RegensburgChirurgieStudienzentrale0941 9446736cotrialassociates(at)ukr.de