Clinical trial · Interventional
Italian Multicenter Study Comparing FOLFOXIRI Versus Gemcitabine as Adjuvant Treatment for Resected Pancreatic Cancer
Phase III Italian Multicenter Study Comparing the Combination of 5-fluorouracil/Folinic Acid, Oxaliplatin and Irinotecan (Folfoxiri) Versus Gemcitabine as Adjuvant Treatment for Resected Pancreatic Cancer
- 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)
Patients with resected pancreatic cancer who fulfill the selection criteria will be randomized to receive one of the two treatment arms for a period of 6 months: Gemcitabine, the standard arm, or FOLFOXIRI (the combination of 5-Fluorouracil/Folinic Acid, Oxaliplatin and Irinotecan), the experimental arm. A total of 310 patients will be enrolled in about 50 Italian centers.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFOXIRI | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine
- description
- Gemcitabine 1000 mg/sqm on days 1,8,15 every 28 days
- interventionNames
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- FOLFOXIRI
- interventionNames
- Drug: FOLFOXIRI
Primary outcomes (1)
- measure
- Disease free survival (DFS)
- timeFrame
- up to 1 year after last patient in
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * histological diagnosis of pancreatic cancer * surgical resection with curative intent within 10 weeks before of enrollment (stage I-III) * absence of evidence of metastases (cM0) * age 18-75 * ECOG performance status 0-1 * adequate bone marrow, liver and renal function * written informed consent Exclusion Criteria: * evidence of metastases * CA19.9 higher than 2.5 x ULN (upper limit of normal range) * precedent chemotherapy or radiotherapy * coexisting malignancies * relevant coexisting diseases that could contraindicate the participation to the study * hypersensitivity/intolerance to the drugs in study * pregnancy or breastfeeding * neurotoxicity of grade \> 1 * malabsorption syndrome
References
Publications (0)
Data not yet available