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Completed

NCT Number: NCT04789980

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Seoul, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.)

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Total administration period

    Time frame: through the first-line chemotheraphy completion, assessed up to 12 months

    Total administration period of the first palliative chemotherapy.

  2. 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)

  3. 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

  4. 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.

Other outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

A Multi-center, Prospective, Observational Study to Evaluate Palliative Chemotherapy Patterns and Prognosis in Patients With Locally Advanced or Metastatic Pancreatic Cancer

Acronym: GALAXY

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2021
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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