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

Pancreatic Cancer Non-resectable Clinical Trial

— HOPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03590275
• Other study ID #: HOPE
• Status: Completed
• Start date: October 2, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2018
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: June 30, 2018
• Est. primary completion date: January 18, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer Non-resectable
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia FPO - IRCSS	Candiolo	Torino
Italy	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS	Meldola	Forlì Cesena
Italy	A.O. Universitaria Pisana - Pisa (Pi) Oncologia Medica	Pisa
Italy	Oncologia ASL BI	Ponderano	Biella
Italy	A.O. Ordine Mauriziano	Torino
Italy	P.O. Molinette Oncologia 1	Torino
Italy	ASL VCO, Ospedale Castelli Verbania	Verbania	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	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.	up to 2 years
Secondary	Progression-free survival	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.	up to 2 years
Secondary	Response rate	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.	up to 2 years
Secondary	Toxicity rate	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.	up to 2 years