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

Metastatic Pancreatic Cancer Clinical Trial

— GALAXY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04789980
• Other study ID #: BR-GTB-OS-401
• Status: Recruiting
• Start date: January 29, 2021
• Est. completion date: January 29, 2025

Study information

• Verified date: June 2023
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: Myung Sook Hong
• Phone: 82-2-708-8238
• Email: mshong[@]boryung.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 29, 2025
• Est. primary completion date: January 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Locally Advanced Pancreatic Cancer
• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse drug reactions(ADR)	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)
Other	Serious adverse drug reactions(SADR)	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)
Other	Adverse drug reactions(ADR) caused delay/discontinuation of planned chemotherapy	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)
Primary	Chemotherapy patterns(Type of the first-line palliative chemotherapy)	Type of the first-line palliative chemotherapy and reasons for therapy selection/discontinuation	Baseline
Primary	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
Primary	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
Primary	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	Total administration period	Total administration period of the first palliative chemotherapy.	through the first-line chemotheraphy completion, assessed up to 12 months
Secondary	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
Secondary	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
Secondary	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