Clinical Trial: Observational Study In Real Life Settings Of The Systemic Treatment Of Well Differentiated, Unresectable Or Metastatic, Progressive Pancreatic Neuroendocrine Tumors (pNET): A Study Of Morbidity And Mortality At 2 Years

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Observational Study In Real Life Settings Of The Systemic Treatment Of Well Differentiated, Unresectable Or Metastatic, Progressive Pancreatic Neuroendocrine Tumors (Pnet): A Study Of Morbidity And Mo

Brief Summary: A descriptive, prospective (partly retrospective), multisite, observational study conducted in France in adult patients treated for a well differentiated, unresectable or metastatic, pancreatic neuroendocrine tumor with disease progression.

Detailed Summary: prospective and retrospective Analyses will be performed using SAS® software
Sponsor: Pfizer

Current Primary Outcome: Progression-Free Survival (PFS) [ Time Frame: at baseline, each 3 to 4 months up to 2 years ]

Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (Weeks) = (first event date minus first dose date plus 1) divided by 7


Original Primary Outcome: Same as current

Current Secondary Outcome: Overall Survival (OS) [ Time Frame: baseline, each visit up to 2 years ]

Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact.


Original Secondary Outcome: Same as current

Information By: Pfizer

Dates:
Date Received: September 2, 2014
Date Started: May 12, 2015
Date Completion: June 5, 2019
Last Updated: May 22, 2017
Last Verified: May 2017