sefulness of primary long-acting granulocyte colony-stimulating factor in pancreatic cancer patients receiving FOLFIRINOX: A Multicenter Prospective and Retrospective Propensity matching study
- Conditions
- Neoplasms
- Registration Number
- KCT0009465
- Lead Sponsor
- Yonsei University Health System, Gangnam Severance Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
? Patients with histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) at initial diagnosis.
? Patients with locally advanced or metastatic pancreatic cancer for whom surgery is not feasible.
? Patients aged 18 years or older.
? Patients with a history of prior chemotherapy or radiation therapy.
? Patients who discontinued chemotherapy within 2 cycles.
? Patients with a follow-up duration of less than 2 months who have not undergone initial response evaluation.
? Recurrent pancreatic cancer following curative surgery.
? Patients with concurrent or suspected hematologic disorders.
? Patients who have undergone bone marrow or stem cell transplantation previously.
? Patients with autoimmune diseases.
? Patients taking steroids or immunosuppressive agents.
? Patients diagnosed with HIV/AIDS.
? Severe liver or kidney disease.
? Active double primary cancer.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of severe neutropenia (grade III-IV), febrile neutropenia
- Secondary Outcome Measures
Name Time Method duration of chemotherapy, dose of chemotherapy, survival outcomes, duration of neutropenia, duration of admission due to neutropenic event, duration of antibiotics usage, incidence of infection(cholangitis, liver abscess), UGT1A1 subgroup analysis