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

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ClinicalTrials.gov Identifier: NCT04133155
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : October 22, 2019
Sponsor:
Collaborators:
Bundang CHA Hospital
Ulsan University Hospital
Information provided by (Responsible Party):
Changhoon Yoo, Asan Medical Center

Tracking Information
First Submitted Date October 17, 2019
First Posted Date October 21, 2019
Last Update Posted Date October 22, 2019
Actual Study Start Date September 16, 2019
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 17, 2019)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04133155 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 17, 2019)
  • Overall survival [ Time Frame: 1 year ]
    Time from the start of 2nd-line nab-P+GEM to death from any cause
  • Objective response rates [ Time Frame: 1 year ]
    Tumor response graded by Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1
  • Toxicity profile [ Time Frame: 1 year ]
    Safety profile graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Retrospective Analysis of 2nd-line Nab-Paclitaxel + Gemcitabine After 1st-line FOLFIRINOX in Pancreatic Cancer
Official 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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pathologically confirmed pancreatic ductal adenocarcinoma who received 2nd-line nab-paclitaxel plus gemcitabine after progression on 1st-line FOLFIRINOX
Condition
  • Pancreatic Cancer
  • Metastatic Pancreatic Cancer
Intervention Drug: nab paclitaxel plus gemcitabine
Nab-paclitaxel 125 mg/m2 weekly for 3 weeks, every 4 weeks Gemcitabine 1000 mg/m2 weekly for 3 weeks, every 4 weeks
Other Name: Abraxane
Study Groups/Cohorts nab-P + GEM
Nab-paclitaxel plus gemcitabine
Intervention: Drug: nab paclitaxel plus gemcitabine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 17, 2019)
103
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2021
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Changhoon Yoo, MD +821099006798 cyoo.amc@gmail.com
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT04133155
Other Study ID Numbers AX-NI-PANC-PI-13883
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Changhoon Yoo, Asan Medical Center
Study Sponsor Asan Medical Center
Collaborators
  • Bundang CHA Hospital
  • Ulsan University Hospital
Investigators
Principal Investigator: Changhoon Yoo, MD Asan Medical Center
PRS Account Asan Medical Center
Verification Date October 2019