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NCT Number: NCT04133155

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

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Metastatic Pancreatic Cancer Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, 05505, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

nab paclitaxel plus gemcitabine

Drug

Nab-paclitaxel 125 mg/m2 weekly for 3 weeks, every 4 weeks Gemcitabine 1000 mg/m2 weekly for 3 weeks, every 4 weeks

Other names: Abraxane

Primary outcomes

  1. Progression-free survival

    Time frame: 1 year

    Time from the start of 2nd-line nab-P + GEM to disease progression or death from any cause, whichever came first

Secondary outcomes

  1. Overall survival

    Time frame: 1 year

    Time from the start of 2nd-line nab-P+GEM to death from any cause

  2. Objective response rates

    Time frame: 1 year

    Tumor response graded by Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1

  3. Toxicity profile

    Time frame: 1 year

    Safety profile graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Bundang CHA Hospital
  • Ulsan University Hospital

Registry information

Official study title

Multicenter Retrospective Analysis for Efficacy and Safety of Second-Line Nab-Paclitaxel Plus Gemcitabine After Progression on 1st-line FOLFIRINOX in Advanced Pancreatic Ductal Adenocarcinoma

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 21, 2019
Registry last updated
Mar 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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