Single-arm phase II study of induction Gemcitabine+nab-paclitaxel followed by gemcitabine and concurrent radiotherapy for locally advanced pancreatic cancer
- Conditions
- ocally advanced pancreatic cancer
- Registration Number
- JPRN-UMIN000027756
- Lead Sponsor
- Department of Hepatobiliary and Pancreatic Oncology Osaka International Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 40
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival (proportion of 2-year survival)
- Secondary Outcome Measures
Name Time Method 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