Locally advanced pancreatic cancer
Conditions
Interventions
Induction chemotherapy: Gem plus NabPTX (30-minute IV of nab paclitaxel at 125 mg/m2 followed by 30-minute IV of gemcitabine at 1,000 mg/m2 on day 1,8 and 15, repeated every 4 weeks, for 12 weeks in
Sponsors
Department of Hepatobiliary and Pancreatic Oncology Osaka International Cancer Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically/cytologically proven adenocarcinoma by diagnostic imaging 2) Without obvious organ metastasis (UICC M0) by chest/abdominal/pelvic CT 3) Diagnosed as UICC-T4 or T3 with invasion to common hepatic artery, hepatic artery proper, or portal vein by abdominal and pelvic CT, so judged as unresectable. 4) Without ascites/pleural effusion by chest CT and abdominal/pelvic CT 5) Without active gastrointestinal ulcer 6) Age from 20 to 80 years. 7) Estimated survival more than three months 8) Without interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT and PO2>=80mmHg and %DLCO>=70% 9) ECOG performance status of 0 or 1 10) No peripheral motor/sensory neuropathy 11) No prior surgical treatment for pancreatic cancer 12) Adequate function of major organs 13) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Severe comorbidities (such as heart failure, renal failure, hepatic failure, paresis of intestine, illeus, poorly controlled diabetes(HbA1c>=10%) and poorly controlled hypertension) 2) History of unstable angina pectoris or myocardial infarction within 6 months before registration. 3) Synchronous or metachronous (within 5 years) malignancies except for early cancer. 4) Infectious disease requiring systemic treatment. 5) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy. 6) Severe psychological disorder. 7) Receiving continuous systemic corticosteroid or immunosuppressant treatment. 8) Unavailability of both allergy to bothe of iodine and gadolinium
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (proportion of 2-year survival) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, CA19-9 response rate, distant metastasis free survival time, progression free survival time, incidecce of adverse events, dose intensity, the rate of treatment related death, the rate of early death, the rate of grade 4 nonhematological toxicity | — |
Countries
Japan
Contacts
Public ContactRyoji Takada
Osaka International Cancer Institute Hepatobiliary and Pancreatic Oncology
Outcome results
None listed