Comparing palliative chemotherapy options for pancreatic cancer patients

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

This study looks at how different palliative chemotherapy options affect people with advanced pancreatic cancer in Korea to see which treatments work best and how they impact quality of life.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Boryung Pharmaceutical Co., Ltd (industry)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Seoul)
• Trial ID: NCT04789980 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the patterns and outcomes of palliative chemotherapy in patients with locally advanced or metastatic pancreatic cancer in Korea. It will collect baseline information from participants, including demographics and medical history, and monitor their treatment progress over 12 months. The study will assess the reasons clinicians choose specific chemotherapy regimens and track various health metrics, including quality of life and adverse reactions. Participants will be followed up at 2, 6, and 12 months to gather comprehensive data on their treatment experience.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 and older with histologically or cytologically confirmed locally advanced or metastatic pancreatic cancer who plan to receive palliative chemotherapy.

Not a fit: Patients with other primary cancers, those currently receiving palliative chemotherapy, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help optimize palliative chemotherapy choices for pancreatic cancer patients, potentially improving their quality of life and treatment outcomes.

How similar studies have performed: While similar studies have explored palliative chemotherapy in pancreatic cancer, this specific approach focusing on real-world clinical settings in Korea is relatively novel.

Eligibility criteria

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.

Where this trial is running

Seoul

• The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul, Korea, Republic of (RECRUITING)

Study contacts

• Study coordinator: Myung Sook Hong

Conditions: Locally Advanced Pancreatic Cancer, Metastatic Pancreatic Cancer, Pancreatic Cancer, Palliative Chemotherapy