Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients with locally advanced or metastatic pancreatic cancer who plan to receive palliative chemotherapy |
Not provided
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Serious adverse drug reactions(SADR) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with locally advanced or metastatic pancreatic cancer who plan to receive palliative chemotherapy. Total 1,000 subjects
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | South Korea |
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
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) |
| 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) |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |