Retrospective Analysis of 2nd-line Nab-Paclitaxel + Gemcitabine After 1st-line FOLFIRINOX in Pancreatic Cancer

Completed

• Conditions: Pancreatic Cancer; Metastatic Pancreatic Cancer
• Interventions: Drug: nab paclitaxel plus gemcitabine

• Registration Number: NCT04133155
• Lead Sponsor: Asan Medical Center

Brief Summary

In this study, clinical data of patients who received 2nd-line Nab-paclitaxel plus Gemcitabine (nab-P+GEM) after progression on 1st-line FOLFIRINOX will be reviewed retrospectively.

Detailed Description

FOLFIRINOX is one of standard 1 st-line regimens for patients with advanced PDAC. However, there is no globally established 2 nd-line regimen after the failure of FOLFIRINOX. Although gemcitabine-based regimens are recommended by multiple guidelines and widely used in daily practice, further analysis is needed to reveal the magnitude of clinical benefit with these regimens. Nab-paclitaxel plus Gemcitabine (Nab-P+Gem) is another standard 1 st-line regimen for PDAC, but there are limited data as 2 nd-line therapy in PDAC. Therefore, the investigators are conducting a multicenter retrospective analysis of 2 nd-line nab-P+Gem after progression on FOLFIRINOX in patients with advanced PDAC.

Study Timeline

• Study Start: 2019-09-16
• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-17
• Study First Posted: 2019-10-21
• Primary Completion: 2020-01-01
• Study Completion: 2020-02-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Pathologically confirmed pancreatic ductal adenocarcinoma
• Administration of 2nd-line nab-paclitaxel plus gemcitabine
• Progression on 1st-line FOLFIRINOX

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Exclusion Criteria

• Pathologic diagnosis other than pancreatic ductal adenocarcinoma
• Administration of nab-paclitaxel plus gemcitabine as 3rd or greater lines of therapy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
nab-P + GEM	nab paclitaxel plus gemcitabine	Nab-paclitaxel plus gemcitabine

Primary Outcome Measures

Name	Time	Method
Progression-free survival	1 year	Time from the start of 2nd-line nab-P + GEM to disease progression or death from any cause, whichever came first

Secondary Outcome Measures

Name	Time	Method
Overall survival	1 year	Time from the start of 2nd-line nab-P+GEM to death from any cause
Objective response rates	1 year	Tumor response graded by Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1
Toxicity profile	1 year	Safety profile graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of