Pancreatic Cancer
Conditions
Interventions
None listed
Sponsors
ONO PHARMACEUTICAL CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who satisfy all the following items are included. 1) Patients who were diagnosed with invasive pancreatic ductal carcinoma with local progression or distant metastasis before the first treatment and underwent systemic chemotherapy 2) Patients who have pathologic diagnosis that is consistent with invasive pancreatic ductal carcinoma 3) Patients who were measured body weight periodically at the beginning of the initial systemic chemotherapies and during the subsequent medical consultation period 4) Received one of the following cancer chemotherapies during the study period - mFOLFIRINOX - GEM+nab-PTX - GEM - GEM+ERL 5) Patients who have not refused secondary use of the clinical information, or participated in the 19-075 Study, the K2011-001 Study, and 2012-0281 Study conducted at the National Cancer Center Hospital East and agreed to secondary use of the existing information
Exclusion criteria
Exclusion criteria: Patients who meet at least one of the following exclusion criteria are not included. 1) Patient who underwent surgical operation of the gastrointestinal tract within the last 6 months starting from the beginning day of the first systemic chemotherapy excluding stent placement in the duodenum or gastrojejunostomy 2) Patients with simultaneously active, double cancer (Stage I intraepithelial carcinoma, intramucosal carcinoma, superficial bladder carcinoma, or other cancers without recurrence for 5 years or more can be registered) 3) Patients with missing of body weight data over 12 weeks in the medical consultation period after the beginning of initial systemic chemotherapy 4) Patients who underwent puncture for ascitic fluid at the beginning of initial systemic chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency of onset and the time to onset of cancer cachexia, in patients who were diagnosed with invasive pancreatic ductal carcinoma with local progression or distant metastasis before the first treatment and underwent systemic chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Relationship between onset of cancer cachexia and changes in laboratory parameter 2) Relationship between cancer cachexia and overall survival 3) Relationship between cancer cachexia and the continuation rate of anticancer chemotherapy 4) Relationship between cancer cachexia and the introduction rate of secondary therapy 5) Relationship between onset of cancer cachexia and introduction rate of tertiary therapy 6) Relationship between cancer cachexia and severity and incidence of anorexia and fatigue 7) Correlation between the changes in body weight of >= 5% or (if BMI> 20 kg/m2 or sarcopenia) weight loss of > 2% and changes in each laboratory parameter during the first systemic chemotherapy period at 12-week intervals evaluated from the beginning day of the first systematic chemotherapy. 8) Correlation between the changes in body weight of >= 5% or (if BMI> 20 kg/m2 or sarcopenia) weight loss of > 2% and the severity and incidence of adverse event (neutropenia, anemia, thrombocytopenia, febrile neutropenia, anorexia, nausea, diarrhea, fatigue, peripheral sensory neuropathy, skin rash) during the first systemic chemotherapy period at 12-week intervals evaluated from the beginning day of the first systemic chemotherapy. 9) The results of primary and secondary endpoints are stratified by the regimen of initial systemic chemotherapy. | — |
Countries
Japan
Contacts
Public ContactShuichi Mitsunaga
National Cancer Center Hospital East Department of Hepatobiliary and Pancreatic Oncology
Outcome results
None listed