Clinical trial · Observational
Observational Retrospective Study of Evaluation of Prognostic Factors in Advanced Pancreatic Cancer Patients Treated With FOLFIRINOX
NCT03590275CI-TRIAL-00033841HOPEcompletedClinicalTrials.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)
The aim of this study is to identify new prognostic factors in patients affected by advanced pancreatic carcinoma treated with first line chemotherapy with FOLFIRINOX regimen. Primary objective is the identification of clinical, laboratory and pathologic factors affecting overall survival of these patients.
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 Non-resectable | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFIRINOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- up to 2 years
- description
- Overall survival is defined as the time from study entry until death from any cause. Patients who are alive at the end of the study will be censored at that point.
Secondary outcomes (3)
- measure
- Progression-free survival
- timeFrame
- up to 2 years
- description
- Progression-free survival is defined as time from study entry until progression of disease (according to RECIST 1.1) or death from any cause. Patients who are alive without having progressed at the end of the study will be censored at their last radiological assessment.
- measure
- Response rate
- timeFrame
- up to 2 years
- description
- Response rate is defined as the fraction of treated patients who achieve a response as defined according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria vers. 1.1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age \>18 years * citologically or histologically confirmed pancreatic carcinoma * disease stage III or IV according to the American Joint Committee on Cancer (AJCC) staging system * access to clinical informations collected before first-line starting * availability of objective response evaluation and survival data * written informed consent Exclusion Criteria: * diagnosis of other neoplasia than pancreatic carcinoma * treatment with drugs other than FOLFIRINOX * treatment with experimental drugs in combination with FOLFIRINOX * unavailability of clinical and pathological data
References
Publications (1)
- DERIVEDFornaro L, Leone F, Vienot A, Casadei-Gardini A, Vivaldi C, Lievre A, Lombardi P, De Luca E, Vernerey D, Sperti E, Musettini G, Satolli MA, Edeline J, Spadi R, Neuzillet C, Falcone A, Pasquini G, Clerico M, Passardi A, Buscaglia P, Meurisse A, Aglietta M, Brac C, Vasile E, Montagnani F. Validated Nomogram Predicting 6-Month Survival in Pancreatic Cancer Patients Receiving First-Line 5-Fluorouracil, Oxaliplatin, and Irinotecan. Clin Colorectal Cancer. 2019 Dec;18(4):e394-e401. doi: 10.1016/j.clcc.2019.08.004. Epub 2019 Sep 4. PMID 31564556