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2021-01-29
2025-01-29
2025-01-29
1000
NCT04789980
Boryung Pharmaceutical Co., Ltd
Boryung Pharmaceutical Co., Ltd
OBSERVATIONAL
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.
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).
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-03-02 | N/A | 2024-06-27 |
2021-03-07 | N/A | 2024-06-28 |
2021-03-10 | N/A | 2024-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Patients Patients with locally advanced or metastatic pancreatic cancer who plan to receive palliative chemotherapy |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Chemotherapy patterns(Type of the first-line palliative chemotherapy) | Type of the first-line palliative chemotherapy and reasons for therapy selection/discontinuation | Baseline |
| Chemotherapy patterns(Type of the second-line palliative chemotherapy) | Type of the second-line palliative chemotherapy for each first-line palliative chemotherapy | up to 12 months |
| Progression-free survival (PFS) | 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) | 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 | Measure Description | Time Frame |
|---|---|---|
| Total administration period | Total administration period of the first palliative chemotherapy. | 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) | 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 | 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. | Baseline, Month 2, Month 6, Month 12 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Myung Sook Hong Phone Number: 82-2-708-8238 Email: mshong@boryung.co.kr |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
