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

Last updated: June 27, 2024
Sponsor: Boryung Pharmaceutical Co., Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

Metastatic Cancer

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT04789980
BR-GTB-OS-401
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients are briefed about the study objectives and methodologies, and express theirconsent 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 wasconfirmed histologically or cytologically.

  4. Patients who plan to receive palliative chemotherapy (e.g., FOLFIRINOX,Gemcitabine-based therapy, etc.)

Exclusion

Exclusion Criteria:

  1. Patients who are diagnosed with any other primary cancer that may influencepancreatic 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 trialsfor drugs or medical devices) or are planning to participate in other clinicaltrials during the study period. However, patients participating in anon-interventional observational study or registry study can be enrolled.

  5. Other patients who are judged by the investigator to be ineligible to participate inthe study.

Study Design

Total Participants: 1000
Study Start date:
January 29, 2021
Estimated Completion Date:
January 29, 2025

Study 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).

Connect with a study center

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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