Pancreatic NeoplasmsNCT05587387
Change of Treatment Landscape and Survival in Metastatic Pancreatic Cancer After Nal-IRI in Republic of Korea
An observational study of Pancreatic Neoplasms, run by Yonsei University at 1 site in South Korea.
Trial summary
Pancreatic cancer is a very aggressive disease and its prognosis is poor. Large proportion of patients diagnosed with pancreatic cancer is already in metastatic or locally advanced phases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- How many people
- 250 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2022to 27 Jul 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In multiple medicatl center, such as Sinchon Severance hospital, Gangnam Severance hospital, Gachon University Gil hospital and Konkuk University hospital, investigators will collect the medical information according to inclusion criteria and exclusion criteria from 2012 to 2021.
Who may be able to join
- Patients initially diagnosed as locally advanced pancreatic cancer or metastatic pancreatic cancer and received chemotherapy between 2012 and 2021
- Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
- Documented metastatic disease; disease status may be measurable or non-measurable as defined by RECIST v1.1 guidelines
- Locally advanced pancreatic cancer; disease status was defined by NCCN guidelines.
- Recovered from the effects of any prior surgery, radiotherapy, or other antineoplastic therapy
- At least 18 years of age
Who cannot join
- Other histology (ex. Neuroendocrine tumor, etc.)
- Cohort 2 (other regimens); Patients who received nal-IRI at least once after diagnosis
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Seungmin Bang, +82)10-6297-9209, bang7028@yuhs.ac
About this study
Pancreatic cancer is a very aggressive disease and its prognosis is poor. Large proportion of patients diagnosed with pancreatic cancer is already in metastatic or locally advanced phases. Although there have been huge improvements in survival for many other cancers over the last few decades, the same isn't true for pancreatic cancer. Median 5-year survival rate for pancreatic cancer is around 10% and there are limited number of treatments approved for pancreatic cancer.
There is no definite consensus on the best second-line chemotherapy for patients with metastatic pancreatic cancer who have progressed after first-line chemotherapy. The randomized phase III study, NAPOLI-1 trial has revealed that liposomal irinotecan (nal-IRI) plus fluorouracil/leucovorin (FL) regimen could be an acceptable treatment option in patients with metastatic pancreatic cancer who had been previously treated with gemcitabine-based chemotherapy.
In this study, The investigators will evaluate how the treatment landscape has been changed since the appearance of nal-IRI in Korea. By retrospectively comparing treatment efficacy and safety outcomes before (cohort 1; without nal-IRI/FL) and after the launch of nal-IRI (cohort 2; with nal-IRI/FL), investigators will identify the degree of improvement in treatment outcome brought about by nal-IRI and will confirm whether the nal-IRI could be applied as an effective treatment option in patients with metastatic pancreatic cancer who failed first-line chemotherapy.
- Conditions
- Pancreatic Neoplasms
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Without Nal-IRI/FL; From Jan. 2012 to Jan. 2018 (Before launch of nal-IRI) | |
| Cohort 2 | With Nal-IRI/FL; From Jan. 2018 to Dec. 2021 (After launch of nal-IRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS1)
the duration from diagnosis of pancreatic cancer to death or last follow-up
- OS1 : the duration from diagnosis of pancreatic cancer to death or last follow-up
Measured: The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. (Up to 100 weeks)
Overall survival (OS 2)
the duration from nal-IRI treatment initiation to death or last follow-up
Measured: The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. (Up to 100 weeks)
Secondary outcomes (4)
Progression free survival
the duration from treatment initiation to disease progression
Measured: The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse (Up to 100 weeks)
Objective response rate
the ratio of complete remission and partial remission
Measured: The assessment of the tumor burden after a given treatment in patients with solid tumors and has a long history(Up to 100 weeks)
Disease control rate
the ratio of complete remission, partial remission and stable disease
Measured: the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents.(Up to 100 weeks)
Adverse event
adverse event during the treatment
Measured: Any undesirable experience associated with the use of a medical product in a patient.(Up to 100 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Jul 2022
- Primary completion27 Jul 2023 (estimated)
- Study completion27 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seungmin Bang, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587387
- Sponsor's protocol ID
- 4-2022-0776
- Status last verified
- Oct 2022
- First submitted
- 26 Sep 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Treatment Landscape and Survival in Metastatic Pancreatic Cancer After Nal-IRI in Republic of Korea
- ClinicalTrials.gov ID
- NCT05587387
- Acronym / sponsor ID
- 4-2022-0776
- Conditions
- Pancreatic Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 27 Jul 2023 (estimated)
- Study completion
- 27 Jul 2023 (estimated)
- First posted
- 20 Oct 2022 (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.
Pancreatic cancer is a very aggressive disease and its prognosis is poor. Large proportion of patients diagnosed with pancreatic cancer is already in metastatic or locally advanced phases. Although there have been huge improvements in survival for many other cancers over the last few decades, the same isn't true for pancreatic cancer. Median 5-year survival rate for pancreatic cancer is around 10% and there are limited number of treatments approved for pancreatic cancer.
There is no definite consensus on the best second-line chemotherapy for patients with metastatic pancreatic cancer who have progressed after first-line chemotherapy. The randomized phase III study, NAPOLI-1 trial has revealed that liposomal irinotecan (nal-IRI) plus fluorouracil/leucovorin (FL) regimen could be an acceptable treatment option in patients with metastatic pancreatic cancer who had been previously treated with gemcitabine-based chemotherapy.
In this study, The investigators will evaluate how the treatment landscape has been changed since the appearance of nal-IRI in Korea. By retrospectively comparing treatment efficacy and safety outcomes before (cohort 1; without nal-IRI/FL) and after the launch of nal-IRI (cohort 2; with nal-IRI/FL), investigators will identify the degree of improvement in treatment outcome brought about by nal-IRI and will confirm whether the nal-IRI could be applied as an effective treatment option in patients with metastatic pancreatic cancer who failed first-line chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Without Nal-IRI/FL; From Jan. 2012 to Jan. 2018 (Before launch of nal-IRI) |
| Cohort 2 | – | –With Nal-IRI/FL; From Jan. 2018 to Dec. 2021 (After launch of nal-IRI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In multiple medicatl center, such as Sinchon Severance hospital, Gangnam Severance hospital, Gachon University Gil hospital and Konkuk University hospital, investigators will collect the medical information according to inclusion criteria and exclusion criteria from 2012 to 2021.
Key inclusion criteria (6 listed)
- Patients initially diagnosed as locally advanced pancreatic cancer or metastatic pancreatic cancer and received chemotherapy between 2012 and 2021
- Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
- Documented metastatic disease; disease status may be measurable or non-measurable as defined by RECIST v1.1 guidelines
- Locally advanced pancreatic cancer; disease status was defined by NCCN guidelines.
- Recovered from the effects of any prior surgery, radiotherapy, or other antineoplastic therapy
Key exclusion criteria (2 listed)
- Other histology (ex. Neuroendocrine tumor, etc.)
- Cohort 2 (other regimens); Patients who received nal-IRI at least once after diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival (OS1)
Time frame: The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. (Up to 100 weeks)
the duration from diagnosis of pancreatic cancer to death or last follow-up - OS1 : the duration from diagnosis of pancreatic cancer to death or last follow-up
Overall survival (OS 2)
Time frame: The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. (Up to 100 weeks)
the duration from nal-IRI treatment initiation to death or last follow-up
4 secondary outcomes
Progression free survival
Time frame: The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse (Up to 100 weeks)
Objective response rate
Time frame: The assessment of the tumor burden after a given treatment in patients with solid tumors and has a long history(Up to 100 weeks)
Disease control rate
Time frame: the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents.(Up to 100 weeks)
Adverse event
Time frame: Any undesirable experience associated with the use of a medical product in a patient.(Up to 100 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- 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.
Seungmin Bang principal investigator
Severance Hospital
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 Neoplasms, run by Yonsei University 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 6 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: status not confirmed, as of the sponsor's last update on 20 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seungmin Bang (+82)10-6297-9209, bang7028@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS1) (time frame: The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. (Up to 100 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2022.