A Multi-center, Prospective, Observational Study to Evaluate Palliative Chemotherapy Patterns and Prognosis in Patients With Locally Advanced or Metastatic Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 799
- 试验地点
- 1
- 主要终点
- Chemotherapy patterns(Type of the second-line palliative chemotherapy)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.)
排除标准
- •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.
结局指标
主要结局
Chemotherapy patterns(Type of the second-line palliative chemotherapy)
时间窗: up to 12 months
Type of the second-line palliative chemotherapy for each first-line palliative chemotherapy
Progression-free survival (PFS)
时间窗: 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
Overall Survival (OS)
时间窗: From date of enrollment until the date of death, assessed up to 12 months
Overall Survival (OS) by first-line palliative chemotherapy
Chemotherapy patterns(Type of the first-line palliative chemotherapy)
时间窗: Baseline
Type of the first-line palliative chemotherapy and reasons for therapy selection/discontinuation
次要结局
- 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)
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) scores(Baseline, Month 2, Month 6, Month 12)
- Quality of Life Assessment(Baseline, Month 2, Month 6)