Locally Advanced Pancreatic CancerGALAXYNCT04789980
Good Choice of pALliative Chemotherapy to Patient With Pancreatic Cancer ; GemcitAbine Therapy vs FOLFORINOX therapY
An observational study of Locally Advanced Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The study objectives are to find out: 1) palliative chemotherapy patterns and prognosis in patients with locally advanced or metastatic pancreatic cancer in Korea's real clinical settings, and 2) reasons adopted by clinicians in choosing therapeutic drugs. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Locally Advanced Pancreatic Cancer, Metastatic Pancreatic Cancer
- How many people
- 799 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jan 2021to 24 Jun 2025
- 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: Patients with locally advanced or metastatic pancreatic cancer who plan to receive palliative chemotherapy. Total 1,000 subjects
Who may be able to join
- Patients are briefed about the study objectives and methodologies, and express their consent by signing a written agreement for the use of their personal information.
- Male and female adults who are ≥ 19 years old at the time of enrollment.
- Locally advanced or metastatic pancreatic cancer patients whose diagnosis was confirmed histologically or cytologically.
- Patients who plan to receive palliative chemotherapy (e.g., FOLFIRINOX, Gemcitabine-based therapy, etc.)
Who cannot join
- Patients who are diagnosed with any other primary cancer that may influence pancreatic cancer treatment or prognosis.
- Patients who are currently or have a history of receiving palliative chemotherapy.
- Female patients who are pregnant, have childbearing potential or are breastfeeding.
- Patients who are currently participating in other clinical trials (clinical trials for drugs or medical devices) or are planning to participate in other clinical trials during the study period. However, patients participating in a non-interventional observational study or registry study can be enrolled.
- Other patients who are judged by the investigator to be ineligible to participate in the study.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
About this study
Official title: A Multi-center, Prospective, Observational Study to Evaluate Palliative Chemotherapy Patterns and Prognosis in Patients With Locally Advanced or Metastatic Pancreatic Cancer
The study objectives are to find out: 1) palliative chemotherapy patterns and prognosis in patients with locally advanced or metastatic pancreatic cancer in Korea's real clinical settings, and 2) reasons adopted by clinicians in choosing therapeutic drugs.
Read the detailed description
This study is a domestic, multi-center, prospective, observational study designed for locally advanced or metastatic pancreatic cancer patients who plan to receive palliative chemotherapy. When patients voluntarily express their consent to provide their information to this study by signing a written agreement, their baseline information including demographics, comorbidities, pancreatic cancer-related information, medical treatment history, etc. shall be used for screening. When patients are judged eligible for study participation, they shall receive an appropriate palliative chemotherapy. After first-line chemotherapy (baseline), information review shall be conducted at month 2, 6 and 12 for chemotherapy currently in use (whether or not chemotherapy ended/discontinued and relevant reasons; type, frequency and duration of administered drugs), RECIST, quality of life (month 2 and 6), activity performance assessment, laboratory tests, tumor marker test, adverse drug reactions, etc. However, if first-line chemotherapy moves to second-line chemotherapy due to causes such as progressive disease (PD), information review shall be restricted to the relevant drug name and survival until the end of the study (month 12).
- Keywords
- Pancreatic Cancer, Palliative Chemotherapy
- 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 |
|---|---|---|
| Patients | Patients with locally advanced or metastatic pancreatic cancer who plan to receive palliative chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy patterns(Type of the first-line palliative chemotherapy)
Type of the first-line palliative chemotherapy and reasons for therapy selection/discontinuation
Measured: Baseline
Chemotherapy patterns(Type of the second-line palliative chemotherapy)
Type of the second-line palliative chemotherapy for each first-line palliative chemotherapy
Measured: up to 12 months
Progression-free survival (PFS)
Progression-free survival (PFS) by first-line palliative chemotherapy
Measured: From date of the first tumor response until the date of first documented progression, assessed up to 12 months
Overall Survival (OS)
Overall Survival (OS) by first-line palliative chemotherapy
Measured: From date of enrollment until the date of death, assessed up to 12 months
Secondary outcomes (4)
Total administration period
Total administration period of the first palliative chemotherapy.
Measured: through the first-line chemotheraphy completion, assessed up to 12 months
The best response
The best response according to RECIST 1.1 criteria, objective response rate (ORR) and disease control rate (DCR)
Measured: through the first-line chemotheraphy completion, assessed up to 12 months
Quality of Life Assessment
Quality of life (FACT-Hep) changes in month 2 and 6 after palliative chemotherapy compared to previous therapy
Measured: Baseline, Month 2, Month 6
Eastern Cooperative Oncology Group Performance Status (ECOG PS) scores
Changes in ECOG PS scores at month 2, 6 and 12 after palliative chemotherapy compared to previous therapy. The minimum value is 0 and the maximum value is 5, and higher scores mean a worse outcome.
Measured: Baseline, Month 2, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start29 Jan 2021
- Primary completion24 Jun 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe 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
- Prospective
- Enrolment
- 799 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789980
- Sponsor's protocol ID
- BR-GTB-OS-401
- Acronym
- GALAXY
- Status last verified
- Sep 2025
- First submitted
- 2 Mar 2021
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Observational Study to Evaluate Palliative Chemotherapy Patterns and Prognosis in Patients With Locally Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04789980
- Acronym / sponsor ID
- GALAXY / BR-GTB-OS-401
- Keywords
- Pancreatic Cancer, Palliative Chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 799 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 10 Mar 2021 (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.
The study objectives are to find out: 1) palliative chemotherapy patterns and prognosis in patients with locally advanced or metastatic pancreatic cancer in Korea's real clinical settings, and 2) reasons adopted by clinicians in choosing therapeutic drugs.
Detailed description
This study is a domestic, multi-center, prospective, observational study designed for locally advanced or metastatic pancreatic cancer patients who plan to receive palliative chemotherapy. When patients voluntarily express their consent to provide their information to this study by signing a written agreement, their baseline information including demographics, comorbidities, pancreatic cancer-related information, medical treatment history, etc. shall be used for screening. When patients are judged eligible for study participation, they shall receive an appropriate palliative chemotherapy. After first-line chemotherapy (baseline), information review shall be conducted at month 2, 6 and 12 for chemotherapy currently in use (whether or not chemotherapy ended/discontinued and relevant reasons; type, frequency and duration of administered drugs), RECIST, quality of life (month 2 and 6), activity performance assessment, laboratory tests, tumor marker test, adverse drug reactions, etc. However, if first-line chemotherapy moves to second-line chemotherapy due to causes such as progressive disease (PD), information review shall be restricted to the relevant drug name and survival until the end of the study (month 12).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients with locally advanced or metastatic pancreatic cancer who plan to receive palliative chemotherapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced or metastatic pancreatic cancer who plan to receive palliative chemotherapy. Total 1,000 subjects
Key inclusion criteria (4 listed)
- Patients are briefed about the study objectives and methodologies, and express their consent by signing a written agreement for the use of their personal information.
- Male and female adults who are ≥ 19 years old at the time of enrollment.
- Locally advanced or metastatic pancreatic cancer patients whose diagnosis was confirmed histologically or cytologically.
- Patients who plan to receive palliative chemotherapy (e.g., FOLFIRINOX, Gemcitabine-based therapy, etc.)
Key exclusion criteria (5 listed)
- Patients who are diagnosed with any other primary cancer that may influence pancreatic cancer treatment or prognosis.
- Patients who are currently or have a history of receiving palliative chemotherapy.
- Female patients who are pregnant, have childbearing potential or are breastfeeding.
- Patients who are currently participating in other clinical trials (clinical trials for drugs or medical devices) or are planning to participate in other clinical trials during the study period. However, patients participating in a non-interventional observational study or registry study can be enrolled.
- Other patients who are judged by the investigator to be ineligible to participate in the study.
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
Chemotherapy patterns(Type of the first-line palliative chemotherapy)
Time frame: Baseline
Type of the first-line palliative chemotherapy and reasons for therapy selection/discontinuation
Chemotherapy patterns(Type of the second-line palliative chemotherapy)
Time frame: up to 12 months
Type of the second-line palliative chemotherapy for each first-line palliative chemotherapy
Progression-free survival (PFS)
Time frame: From date of the first tumor response until the date of first documented progression, assessed up to 12 months
Progression-free survival (PFS) by first-line palliative chemotherapy
Overall Survival (OS)
Time frame: From date of enrollment until the date of death, assessed up to 12 months
Overall Survival (OS) by first-line palliative chemotherapy
4 secondary outcomes
Total administration period
Time frame: through the first-line chemotheraphy completion, assessed up to 12 months
The best response
Time frame: through the first-line chemotheraphy completion, assessed up to 12 months
Quality of Life Assessment
Time frame: Baseline, Month 2, Month 6
Eastern Cooperative Oncology Group Performance Status (ECOG PS) scores
Time frame: Baseline, Month 2, Month 6, Month 12
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 12 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Locally Advanced Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Boryung Pharmaceutical Co., Ltd 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 4 inclusion and 5 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 12 Sep 2025. 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?
Chemotherapy patterns(Type of the first-line palliative chemotherapy) (time frame: Baseline). The study lists 4 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 12 Sep 2025.