Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-29 @ 3:25 PM
Study NCT ID:
NCT02896803
Status:
UNKNOWN
Last Update Posted:
2020-11-10
First Post:
2016-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluorouracil and Oxaliplatin as First-line for Advanced Pancreatic Cancer
Sponsor:
Instituto do Cancer do Estado de São Paulo
Organization:
Study Overview
Official Title:
A Phase II Trial of Bolus Fluorouracil and Oxaliplatin (mFLOX) as First-line Regimen for Patients With Unresectable or Metastatic Pancreatic Cancer Not Eligible for Infusional Fluorouracil, Irinotecan and Oxaliplatin
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
RECRUITING
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:
PanFLOX
Brief Summary:
Patients with locally advanced or metastatic pancreatic adenocarcinoma not eligible for infusional fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX) (PPS 2 or hyperbilirubinemia, among other causes) will be treated with mFLOX regimen (fluorouracil bolus and oxaliplatin). The primary endpoint is to assess the objective response rate according to RECIST criteria (version 1.1) and the secondary endpoints are time until clinical or radiological progression, overall survival, toxicity profile.
Detailed Description:
Currently, FOLFIRINOX is considered the standard treatment for PS 0 or 1 patients with advanced pancreatic carcinoma. However, due to excessive toxicity dose reductions and interruptions in the treatment toxicity are frequent. So, for those not eligible patients (PS 2 or 3, hyperbilirubinemia, among other causes), alternative schemes as gemcitabine alone are the standard approach .
This study aims to evaluate the efficacy and safety of the mFLOX regimen (fluorouracil bolus and oxaliplatin) as first-line regimen for advanced pancreatic adenocarcinoma not eligible for FOLFIRINOX.
The primary endpoint is to assess the objective response rate according to RECIST criteria (version 1.1) and the secondary endpoints are time until clinical or radiological progression, overall survival, toxicity profile.
It has been estimated an n=34 for a response rate of 20%, compared to the historical control of 7% with gemcitabine alone (Von Hoff et al.), with an alpha error of 5% and power of 80%. Considering a rate of 10% of dropout, our sample will be 37 patients.
This study aims to evaluate the efficacy and safety of the mFLOX regimen (fluorouracil bolus and oxaliplatin) as first-line regimen for advanced pancreatic adenocarcinoma not eligible for FOLFIRINOX.
The primary endpoint is to assess the objective response rate according to RECIST criteria (version 1.1) and the secondary endpoints are time until clinical or radiological progression, overall survival, toxicity profile.
It has been estimated an n=34 for a response rate of 20%, compared to the historical control of 7% with gemcitabine alone (Von Hoff et al.), with an alpha error of 5% and power of 80%. Considering a rate of 10% of dropout, our sample will be 37 patients.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: