Good Choice of pALliative Chemotherapy to Patient With Pancreatic Cancer ; GemcitAbine Therapy vs FOLFORINOX therapY (GALAXY)

September 11, 2025 updated by: Boryung Pharmaceutical Co., Ltd

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

799

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea
        • The Catholic University of Korea, Seoul St. Mary's Hospital

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with locally advanced or metastatic pancreatic cancer who plan to receive palliative chemotherapy. Total 1,000 subjects

Description

Inclusion Criteria:

  1. 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.
  2. Male and female adults who are ≥ 19 years old at the time of enrollment.
  3. Locally advanced or metastatic pancreatic cancer patients whose diagnosis was confirmed histologically or cytologically.
  4. Patients who plan to receive palliative chemotherapy (e.g., FOLFIRINOX, Gemcitabine-based therapy, etc.)

Exclusion Criteria:

  1. Patients who are diagnosed with any other primary cancer that may influence pancreatic cancer treatment or prognosis.
  2. Patients who are currently or have a history of receiving palliative chemotherapy.
  3. Female patients who are pregnant, have childbearing potential or are breastfeeding.
  4. 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.
  5. Other patients who are judged by the investigator to be ineligible to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients
Patients with locally advanced or metastatic pancreatic cancer who plan to receive palliative chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline
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
up to 12 months
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
From date of the first tumor response until the date of first documented progression, assessed up to 12 months
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
From date of enrollment until the date of death, assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total administration period
Time Frame: through the first-line chemotheraphy completion, assessed up to 12 months
Total administration period of the first palliative chemotherapy.
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
The best response according to RECIST 1.1 criteria, objective response rate (ORR) and disease control rate (DCR)
through the first-line chemotheraphy completion, assessed up to 12 months
Quality of Life Assessment
Time Frame: Baseline, Month 2, Month 6
Quality of life (FACT-Hep) changes in month 2 and 6 after palliative chemotherapy compared to previous therapy
Baseline, Month 2, Month 6
Eastern Cooperative Oncology Group Performance Status (ECOG PS) scores
Time Frame: Baseline, Month 2, Month 6, Month 12
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.
Baseline, Month 2, Month 6, Month 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse drug reactions(ADR)
Time Frame: From the date of the first-line chemotheraphy started until the end of follow-up(12 months)
Incidence of adverse drug reactions (ADR) associated with first-line palliative chemotherapy
From the date of the first-line chemotheraphy started until the end of follow-up(12 months)
Serious adverse drug reactions(SADR)
Time Frame: From the date of the first-line chemotheraphy started until the end of follow-up(12 months)
Incidence of serious adverse drug reactions (SADR) associated with first-line palliative chemotherapy
From the date of the first-line chemotheraphy started until the end of follow-up(12 months)
Adverse drug reactions(ADR) caused delay/discontinuation of planned chemotherapy
Time Frame: From the date of the first-line chemotheraphy started until the end of follow-up(12 months)
Incidence of ADRs that caused delay/discontinuation of planned chemotherapy
From the date of the first-line chemotheraphy started until the end of follow-up(12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boryung Pharmaceutical Co., Ltd

Study record dates

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 Major Dates

Study Start (Actual)

January 29, 2021

Primary Completion (Actual)

June 24, 2025

Study Completion (Actual)

June 24, 2025

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 7, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 11, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-GTB-OS-401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Pancreatic Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe