Clinical trial · Interventional
Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant / Adjuvant FOLFIRINOX for Resectable Pancreas Carcinoma
Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer
NCT02172976CI-TRIAL-00046921completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this multicenter study, patients with resectable pancreatic carcinoma will be treated with (a) surgery followed by 6 cycles gemcitabine or (b) 4-6 cycles FOLFIRINOX followed by surgery followed by 4-6 cycles FOLFIRINOX. The overall survival between both therapies will be compared as well as other parameters.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Resectable Prancreas Carcinoma | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Natriumfolinate | Drug | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FOLFIRINOX
- description
- Oxaliplatin 85mg/m², Irinotecan 180mg/m², 5-FU 400mg/m² Bolus i.v., 5-FU continuous Infusion 2400 mg/m² Natriumfolinate 400mg/m² 46h d1; qd15 6 cycles pre- and 6 cycles post- surgery
- interventionNames
- Drug: Oxaliplatin
- Drug: 5-Fluorouracil
- Drug: Irinotecan
- Drug: Natriumfolinate
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine
- description
- Gemcitabine 1000 mg/m² d1, d8, d15; qd 29; 6 cycles after surgery
- interventionNames
- Drug: Gemcitabine
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the pankreas. For histological confirmation, max. 3 tests are allowed. If no confirmation of carcinoma is possible, the patient can not be included into the study. 2. Radiological confirmation of a locally limited curativ resectable (primarily resectale or borderline situation) pankreas carcinoma without distant metastases. 3. no prior pancreas resection 4. no prior cytostatic chemotherapy 5. female and male patients \> 18 and \<=75 years using contraception 6. ECOG ≤ 1 7. medical resectability 8. granulocytes \> 1.500/µl 9. thrombocytes \> 100.000/µl 10. hemoglobin ≥ 8,0 g/dl 11. serumcreatinine ≤ 1.5x of normal value or Creatinine-Clearance \> 50 ml/min 12. written informed consent Exclusion Criteria: 1. Endocrine pancreas carcinoma 2. locally advanced inoperable stages: non-resectable infiltration of V. porta or longway infiltration of A. mesenterica superior or infiltration of Truncus coeliacus. 3. distant metastases 4. Relapse 5. prior radiotherapy of measurable lesions 6. peritonealcarcinosis 7. malignant secondary disease, dated back \< 5 years (exeption: in-situ-carcinoma of the cervix, adequately treated skin basal cell carcinoma) 8. contraindication for operative resection 9. ECOG ≥ 2 10. severe liver dysfunction (AST/ALT\>3,5xULN, AP\>6xULN) 11. Transhepatic drainage 12. active CHD (symptoms present), cardiomyopathy or heart insufficiency stage III-IV according to NYHA and EF \< 45% 13. severe non-surgical accompanying diseases or acute infection 14. chronic diarrhea 15. chronic inflammable gastro-intestinal disease 16. peripheral polyneuropathy \> NCI grade II 17. pregnancy or lactation 18. hypersensibility or contraindication for Gemcitabine, Oxaliplatin, Natriumfolinate, Irinotecan or 5-Fluorouracil 19. participation in another interventional trial
References
Publications (0)
Data not yet available
No reference posted for this study.