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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03590275
Other study ID # HOPE
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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