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

NCT04789980 | Completed

• 1 other identifier: BR-GTB-OS-401
• Study Type: observational
• Target: 799
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced Pancreatic Cancer; Metastatic Pancreatic Cancer

Keywords

Pancreatic Cancer; Palliative Chemotherapy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Total administration period

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

• The best response

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

• Quality of Life Assessment

  Baseline, Month 2, Month 6

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) scores

  Baseline, Month 2, Month 6, Month 12

Other Outcomes (3)

• Adverse drug reactions(ADR)

  From the date of the first-line chemotheraphy started until the end of follow-up(12 months)

• Serious adverse drug reactions(SADR)

  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

  From the date of the first-line chemotheraphy started until the end of follow-up(12 months)

Study Arms (1)

Patients

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 10, 2021
• Study Start: January 29, 2021
• Primary Completion: June 24, 2025
• Study Completion: June 24, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

KR (1)