Observational Retrospective Study of Evaluation of Prognostic Factors in Advanced Pancreatic Cancer Patients Treated With FOLFIRINOX

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.

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Key information

Conditions

Pancreatic Cancer Non-resectable Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oncologia ASL BI, Ponderano, Biella, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Folfirinox

Drug

Patients treated with first-line FOLFIRINOX (oxaliplatin + irinotecan + lederfolin + 5-fluorouracil) as per clinical practice were included in the study

Primary outcomes

Overall survival

Time frame: 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 outcomes

Progression-free survival

Time frame: 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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero, Universitaria Pisana

Other

Registry information

Acronym: HOPE

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Jul 18, 2018
Registry last updated: Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed