Pancreatic Cancer Non-resectable
Conditions
Keywords
pancreatic cancer, chemotherapy, FOLFIRINOX, prognostic
Brief summary
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.
Interventions
DRUGFOLFIRINOX
Patients treated with first-line FOLFIRINOX (oxaliplatin + irinotecan + lederfolin + 5-fluorouracil) as per clinical practice were included in the study
Sponsors
Azienda Ospedaliero, Universitaria Pisana
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | up to 2 years | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | up to 2 years | 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. |
| Response rate | up to 2 years | 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. |
| Toxicity rate | up to 2 years | Toxicity Rate is defined as the percentage of patients, relative to the total of enrolled subjects, experiencing treatment-related adverse events as assessed by National Cancer Institute Common Toxicity Criteria (version 4.0), during chemotherapy. |
Countries
Italy
Outcome results
None listed