Pancreatic cancer
Conditions
Interventions
Group A (a group for Gem therapy alone): Gem is intravenously administered at a dose of 1,000 mg/m^2/day in 30 minutes on day 1, day 8 and day 15 as 4 weeks (28 days) for 1 course, until it satisfies
Sponsors
National Hospital Organization Shikoku Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are diagnosed with adenocarcinoma in tissue biopsy or cytology and whose image diagnosis do not contradict any of papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma or adenous squamous cell carcinoma. 2. Patients who are diagnosed with either locally advanced (UICC T4N0-1 M0: stage III), distant metastasis (UICC M1: stage IV) or recurrent (after resection) pancreatic cancer in clinical and image diagnoses. 3. Patients without retention of body cavity fluid (pleural effusion, ascites) which requires puncture drainage on chest x-rays and abdominal CT. 4. Patients who are 75 years old or older at the time of registration. 5. Patients with performance status (ECOG) of grade 0 or 1. 6. Patients without a history of chemotherapy for pancreatic cancer. 7. Patients who have had rest period of a half year or more since the end of prior treatment of either chemotherapy or radiotherapy for other cancer types. 8. Patients who satisfies all of the following conditions. 1).White blood cell count => 3,000 /mm^3 and <= 12,000 /mm^3 2).Hemoglobin => 9.0 g/dL (without transfusion within 14 days until the time of registration) 3).Number of platelets => 10*10^4 /mm^3 4).Albumin => 3.0g/dL 5).Total bilirubin without preoperative biliary drainage: <= 2.0 mg/dL, with preoperative biliary drainage: <= 3.0 mg/dL 6).AST without preoperative biliary drainage: <= 100 IU/L, with preoperative biliary drainage <= 150 IU/L 7).ALT without preoperative biliary drainage: <= 100 IU/L, with preoperative biliary drainage: <= 150 IU/L 8).Creatinine clearance => 50 mL/min/body 9).CRP <= 2.0 mg/dL 9. Patients who provided written consents for this study by themselves.
Exclusion criteria
Exclusion criteria: 1. Patients to whom gemcitabine hydrochloride plus nab-paclitaxel (brand name: Abraxane) can be introduced at the discretion of the attending doctor under consent of the patient. 2. Patients with active advanced multiple primary cancers with life expectancy within a half year. 3. Patients with a bacterial infection which requires systemic treatment by intravenous administration of antibiotic. 4. Patients with a complication of psychosis or psychiatric symptoms (including dementia) who are decided not suitable for participation in this study. 5. Patients who have undergone continuous systemic administration of steroids. 6. Patients with pulmonary fibrosis or interstitial pneumonia. 7. Patients with serious complications. 8. Patients with a complication of unstable angina or a history of myocardial infarction within 6 months. 9. Patients who require continuous administration of flucytosine, phenytoin and warfarin potassium. 10. Patients to whom neither iodine drug nor gadolinium can be used for drug allergy. 11. Patients for whom the principal investigator or other investigators decided not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of adverse event, incidence rate of serious adverse event, progression-free survival, response rate | — |
Countries
Japan
Contacts
Public ContactHiroshi Ishii
National Hospital Organization Shikoku Cancer Center Clinical Research Center
Outcome results
None listed