Viewing Study NCT04769414



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Study NCT ID: NCT04769414
Status: COMPLETED
Last Update Posted: 2022-08-08
First Post: 2021-02-19

Brief Title: Flouro-Gem in Adenocarcinoma of the Pancreas GEFLUPAN
Sponsor: Menoufia University
Organization: Menoufia University

Study Overview

Official Title: A Phase II Trial of Flouro-Gem as a First Line Treatment of Metastatic Adenocarcinoma of the Pancreas GEFLUPAN
Status: COMPLETED
Status Verified Date: 2022-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: In this study the investigators designed a treatment regimen including the most active agents in pancreatic cancer which are gemcitabine and fluorouracil to be tested as a first line treatment This regimen is expected to be less toxic than FOLFIRINOX and aiming at better outcomes
Detailed Description: Metastatic cancer pancreas has been a challenge for oncologists over the years It is a disease of limited survival and a very poor response to treatment The median overall survival at five years is expected to be between 4-6 only Adenocarcinoma is the most common type of pancreatic cancer It is the tenth most common adult solid malignancy Most of the new therapeutic modalities has proven to be non-beneficial in this disease including targeted and immunotherapy

For many years the first line of treatment for pancreatic cancer was gemcitabine either alone or in combinations Recently FOLFIRINOX has become the standard of care due to its overall survival benefit However it is a small benefit on the expense of great toxicity

Patients with metastatic cancer pancreas are recruited to receive the test regimen Baseline evaluation will be done either by CT scan or PETCT re-evaluation will be repeated after 3 months of treatment and at end of 6 months

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None