Clinical trial NCT04789980: Good Choice of pALliative Chemotherapy to Patient With Pancreatic Cancer ; GemcitAbine Therapy vs FOLFORINOX therapY
Official title: A Multi-center, Prospective, Observational Study to Evaluate Palliative Chemotherapy Patterns and Prognosis in Patients With Locally Advanced or Metastatic Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Locally Advanced Pancreatic Cancer
Metastatic Pancreatic Cancer
Keywords: Pancreatic Cancer
Palliative Chemotherapy
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-03-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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).

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.

Primary outcomes:
measure: Chemotherapy patterns(Type of the first-line palliative chemotherapy)
timeFrame: Baseline
measure: Chemotherapy patterns(Type of the second-line palliative chemotherapy)
timeFrame: up to 12 months
measure: Progression-free survival (PFS)
timeFrame: From date of the first tumor response until the date of first documented progression, assessed up to 12 months
measure: Overall Survival (OS)
timeFrame: From date of enrollment until the date of death, assessed up to 12 months
Secondary outcomes:
measure: Total administration period
timeFrame: through the first-line chemotheraphy completion, assessed up to 12 months
measure: The best response
timeFrame: through the first-line chemotheraphy completion, assessed up to 12 months
measure: Quality of Life Assessment
timeFrame: Baseline, Month 2, Month 6
measure: Eastern Cooperative Oncology Group Performance Status (ECOG PS) scores
timeFrame: Baseline, Month 2, Month 6, Month 12
Other outcomes:
measure: Adverse drug reactions(ADR)
timeFrame: From the date of the first-line chemotheraphy started until the end of follow-up(12 months)
measure: Serious adverse drug reactions(SADR)
timeFrame: From the date of the first-line chemotheraphy started until the end of follow-up(12 months)
measure: Adverse drug reactions(ADR) caused delay/discontinuation of planned chemotherapy
timeFrame: From the date of the first-line chemotheraphy started until the end of follow-up(12 months)
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
Study officials:
References: