NCT04789980

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 799 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Locally Advanced Pancreatic Cancer
• Metastatic Pancreatic Cancer

Timeline

• Start date: 2021-01-29
• Primary completion: 2025-06-24
• Completion: 2025-06-24
• First posted: 2021-03-10
• Last updated: 2025-09-12

Locations

1 site across 1 country: South Korea