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2019-09-16
2020-01-01
2020-02-01
103
NCT04133155
Asan Medical Center
Asan Medical Center
OBSERVATIONAL
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-10-17 | N/A | 2020-03-12 |
2019-10-17 | N/A | 2020-03-13 |
2019-10-21 | N/A | 2020-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : nab-P + GEM Nab-paclitaxel plus gemcitabine | DRUG: nab paclitaxel plus gemcitabine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Progression-free survival | Time from the start of 2nd-line nab-P + GEM to disease progression or death from any cause, whichever came first | 1 year |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall survival | Time from the start of 2nd-line nab-P+GEM to death from any cause | 1 year |
| Objective response rates | Tumor response graded by Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 | 1 year |
| Toxicity profile | Safety profile graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 | 1 year |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
