Pancreatic CancerNCT04133155
Retrospective Analysis of 2nd-line Nab-Paclitaxel + Gemcitabine After 1st-line FOLFIRINOX in Pancreatic Cancer
An observational study of Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pancreatic Cancer, Metastatic Pancreatic Cancer
- What is being tested?
- nab paclitaxel plus gemcitabine
- How many people
- 103 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Sep 2019to 1 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pathologically confirmed pancreatic ductal adenocarcinoma who received 2nd-line nab-paclitaxel plus gemcitabine after progression on 1st-line FOLFIRINOX
Who may be able to join
- Pathologically confirmed pancreatic ductal adenocarcinoma
- Administration of 2nd-line nab-paclitaxel plus gemcitabine
- Progression on 1st-line FOLFIRINOX
Who cannot join
- Pathologic diagnosis other than pancreatic ductal adenocarcinoma
- Administration of nab-paclitaxel plus gemcitabine as 3rd or greater lines of therapy
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pancreatic Cancer, Metastatic Pancreatic Cancer
- Being tested
- nab paclitaxel plus gemcitabine
- Keywords
- Pancreatic cancer, FOLFIRINOX, nab-paclitaxel plus gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nab paclitaxel plus gemcitabineDrug
Also called Abraxane
Nab-paclitaxel 125 mg/m2 weekly for 3 weeks, every 4 weeks Gemcitabine 1000 mg/m2 weekly for 3 weeks, every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| nab-P + GEM | Nab-paclitaxel plus gemcitabine Receives: Drug: nab paclitaxel plus gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Time from the start of 2nd-line nab-P + GEM to disease progression or death from any cause, whichever came first
Measured: 1 year
Secondary outcomes (3)
Overall survival
Time from the start of 2nd-line nab-P+GEM to death from any cause
Measured: 1 year
Objective response rates
Tumor response graded by Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1
Measured: 1 year
Toxicity profile
Safety profile graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start16 Sep 2019
- Primary completion1 Jan 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bundang CHA Hospital, Ulsan University Hospital
- Responsible party
- Principal investigator, Changhoon Yoo, Asan Medical Center
- Investigators
- Changhoon Yoo, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133155
- Sponsor's protocol ID
- AX-NI-PANC-PI-13883
- Status last verified
- Mar 2020
- First submitted
- 17 Oct 2019
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
da Rocha Lino A, Abrahao CM, Brandao RM, Gomes JR, Ferrian AM, Machado MC, Buzaid AC, Maluf FC, Peixoto RD. Role of gemcitabine as second-line therapy after progression on FOLFIRINOX in advanced pancreatic cancer: a retrospective analysis. J Gastrointest Oncol. 2015 Oct;6(5):511-5. doi: 10.3978/j.issn.2078-6891.2015.041.
PubMed 26487945Kang J, Yoo C, Hwang HS, Hong SM, Kim KP, Kim SY, Hong YS, Kim TW, Ryoo BY. Efficacy and safety of lanreotide in Korean patients with metastatic, well-differentiated gastroenteropancreatic-neuroendocrine tumors: a retrospective analysis. Invest New Drugs. 2019 Aug;37(4):763-770. doi: 10.1007/s10637-018-0710-x. Epub 2018 Dec 10.
PubMed 30536151Portal A, Pernot S, Siauve N, Landi B, Lepere C, Colussi O, Rougier P, Zaanan A, Verriere B, Taieb J. Sustained response with gemcitabine plus Nab-paclitaxel after folfirinox failure in metastatic pancreatic cancer: report of an effective new strategy. Clin Res Hepatol Gastroenterol. 2014 Apr;38(2):e23-6. doi: 10.1016/j.clinre.2014.01.005. Epub 2014 Feb 18.
PubMed 24559766Sarabi M, Mais L, Oussaid N, Desseigne F, Guibert P, De La Fouchardiere C. Use of gemcitabine as a second-line treatment following chemotherapy with folfirinox for metastatic pancreatic adenocarcinoma. Oncol Lett. 2017 Jun;13(6):4917-4924. doi: 10.3892/ol.2017.6061. Epub 2017 Apr 20.
PubMed 28599496Chae H, Jeong H, Cheon J, Chon HJ, Ryu H, Kim IH, Kang MJ, Jeong JH, Ryoo BY, Kim KP, Yoo C. Efficacy and safety of second-line nab-paclitaxel plus gemcitabine after progression on FOLFIRINOX for unresectable or metastatic pancreatic ductal adenocarcinoma: multicenter retrospective analysis. Ther Adv Med Oncol. 2020 May 27;12:1758835920923424. doi: 10.1177/1758835920923424. eCollection 2020.
PubMed 32523632
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04133155
- Acronym / sponsor ID
- AX-NI-PANC-PI-13883
- Conditions
- Pancreatic Cancer, Metastatic Pancreatic Cancer
- Keywords
- Pancreatic cancer, FOLFIRINOX, nab-paclitaxel plus gemcitabine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Bundang CHA Hospital, Ulsan University Hospital
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nab-P + GEM | – | Drug: nab paclitaxel plus gemcitabineNab-paclitaxel plus gemcitabine |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pathologically confirmed pancreatic ductal adenocarcinoma who received 2nd-line nab-paclitaxel plus gemcitabine after progression on 1st-line FOLFIRINOX
Key inclusion criteria (3 listed)
- Pathologically confirmed pancreatic ductal adenocarcinoma
- Administration of 2nd-line nab-paclitaxel plus gemcitabine
- Progression on 1st-line FOLFIRINOX
Key exclusion criteria (2 listed)
- Pathologic diagnosis other than pancreatic ductal adenocarcinoma
- Administration of nab-paclitaxel plus gemcitabine as 3rd or greater lines of therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nab paclitaxel plus gemcitabineAlso: AbraxaneNab-paclitaxel 125 mg/m2 weekly for 3 weeks, every 4 weeks Gemcitabine 1000 mg/m2 weekly for 3 weeks, every 4 weeks | Drug | nab-P + GEM |
Primary outcome
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
3 secondary outcomes
Overall survival
Time frame: 1 year
Objective response rates
Time frame: 1 year
Toxicity profile
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Background: PubMed 26487945da Rocha Lino A, Abrahao CM, Brandao RM, Gomes JR, Ferrian AM, Machado MC, Buzaid AC, Maluf FC, Peixoto RD. Role of gemcitabine as second-line therapy after progression on FOLFIRINOX in advanced pancreatic cancer: a retrospective analysis. J Gastrointest Oncol. 2015 Oct;6(5):511-5. doi: 10.3978/j.issn.2078-6891.2015.041.
- Background: PubMed 30536151Kang J, Yoo C, Hwang HS, Hong SM, Kim KP, Kim SY, Hong YS, Kim TW, Ryoo BY. Efficacy and safety of lanreotide in Korean patients with metastatic, well-differentiated gastroenteropancreatic-neuroendocrine tumors: a retrospective analysis. Invest New Drugs. 2019 Aug;37(4):763-770. doi: 10.1007/s10637-018-0710-x. Epub 2018 Dec 10.
- Background: PubMed 24559766Portal A, Pernot S, Siauve N, Landi B, Lepere C, Colussi O, Rougier P, Zaanan A, Verriere B, Taieb J. Sustained response with gemcitabine plus Nab-paclitaxel after folfirinox failure in metastatic pancreatic cancer: report of an effective new strategy. Clin Res Hepatol Gastroenterol. 2014 Apr;38(2):e23-6. doi: 10.1016/j.clinre.2014.01.005. Epub 2014 Feb 18.
- Background: PubMed 28599496Sarabi M, Mais L, Oussaid N, Desseigne F, Guibert P, De La Fouchardiere C. Use of gemcitabine as a second-line treatment following chemotherapy with folfirinox for metastatic pancreatic adenocarcinoma. Oncol Lett. 2017 Jun;13(6):4917-4924. doi: 10.3892/ol.2017.6061. Epub 2017 Apr 20.
- Derived from this study: PubMed 32523632Chae H, Jeong H, Cheon J, Chon HJ, Ryu H, Kim IH, Kang MJ, Jeong JH, Ryoo BY, Kim KP, Yoo C. Efficacy and safety of second-line nab-paclitaxel plus gemcitabine after progression on FOLFIRINOX for unresectable or metastatic pancreatic ductal adenocarcinoma: multicenter retrospective analysis. Ther Adv Med Oncol. 2020 May 27;12:1758835920923424. doi: 10.1177/1758835920923424. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changhoon Yoo, MD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04133155, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.