The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
NCT Number: NCT04789980
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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Notify Me19 year and older
All sexes
Observational
Seoul, South Korea
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Type of the first-line palliative chemotherapy and reasons for therapy selection/discontinuation
Time frame: up to 12 months
Type of the second-line palliative chemotherapy for each first-line palliative chemotherapy
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
Time frame: From date of enrollment until the date of death, assessed up to 12 months
Overall Survival (OS) by first-line palliative chemotherapy
Time frame: through the first-line chemotheraphy completion, assessed up to 12 months
Total administration period of the first palliative chemotherapy.
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)
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
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.
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
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
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
Boryung Pharmaceutical Co., Ltd
Industry
A Multi-center, Prospective, Observational Study to Evaluate Palliative Chemotherapy Patterns and Prognosis in Patients With Locally Advanced or Metastatic Pancreatic Cancer
Acronym: GALAXY
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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