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

Sponsor

Azienda Ospedaliero, Universitaria Pisana (Other)

Overall Status

Completed

CT.gov ID

NCT03590275

Collaborator

(none)

343

Enrollment

Locations

8.9

Actual Duration (Months)

Patients Per Site

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Non-resectable	Drug: FOLFIRINOX

Study Design

Study Type:

Observational

Actual Enrollment :

343 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 2, 2017

Actual Primary Completion Date :

Jan 18, 2018

Actual Study Completion Date :

Jun 30, 2018

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oncologia ASL BI	Ponderano	Biella	Italy	13875
2	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS	Meldola	Forlì Cesena	Italy	47014
3	Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia FPO - IRCSS	Candiolo	Torino	Italy	10060
4	ASL VCO, Ospedale Castelli Verbania	Verbania	Torino	Italy	28922
5	A.O. Universitaria Pisana - Pisa (Pi) Oncologia Medica	Pisa		Italy	56012
6	P.O. Molinette Oncologia 1	Torino		Italy	10126
7	A.O. Ordine Mauriziano	Torino		Italy	10128