pancreatic canser Pancreatic cancer
Conditions
Interventions
Assignment between S-1 treatment group and Nanoliposomal irinotecan with fluorouracil treatment group
between S-1 treatment group and Nanoliposomal irinotecan with fluorouracil treatment
Sponsors
Hirooka Yoshiki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients received sufficient explanation, and then obtained written inforned consent by with sufficient understanding. 2. Patients aged 20 at the time of inforned consent 3. Patients diagnosed with pancreatic cancer based on the diagnostic criteria for pancreatic cancer 4. Contains anti-cancer agents other than S-1 or S-1 + other for unresectable advanced pancreatic cancer . Implementation of neoadjuvant chemotherapy with anticancer drugs other than S-1 If it worsens and is judged to be unresectable, it is considered as initial treatment and registered. 5. Patients with ECOG Performance Status (PS) 0-2. 6. Cases in which the functions of major organs are sufficiently maintained. 1 White blood cell count: 3,500 / mm3 or more 2 Number of neutrophils: 2,000 / mm3 or more 3 Amount of hemoglobin: 9.0 g / dL or more 4 Platelet count: 100,000 / mm3 or more 5 Total bilirubin value: 2.0 mg / dL or less 6 AST and ALT values: 150 U / L or less
Exclusion criteria
Exclusion criteria: 1. Patients who have a history of intestinal obstruction or undergone of resection of pancreatic canser. 2. Patients who have been receiving radiation therapy. 3. Other patients who are judged to be inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Health-related quality of life (EQ-5D, EORTC-C30), overall survival (OS), Treatment success period (TTF), response rate (RR), frequency and extent of adverse events | — |
Contacts
Public ContactKazunori Nakaoka
Fujita Health University Hospital
Outcome results
None listed