Randomized phase II study of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel combination therapy for locally advanced pancreatic cancer (JCOG1407, LAPC-mFOLFIRINOX/GnP-rP2)
- Conditions
- locally advanced pancreatic cancer
- Registration Number
- JPRN-UMIN000023143
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 124
Not provided
1) Synchronous or metachronous (within 5 years) malignancies. 2) Infectious disease requiring systemic treatment. 3) Pyrexia of 38 degrees centigrade or higher. 4) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy. 5) Severe psychological disorder. 6) Receiving continuous systemic corticosteroid or immunosuppressant treatment. 7) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT 8) Severe comorbidities (such as heart failure, renal failure, hepatic failure, paresis of intestine, illeus, poorly controlled diabetes and poorly controlled hypertension) 9) History of unstable angina pectoris or myocardial infarction within 6 months before registration. 10) Allergy to iodine and gadolinium
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival (proportion of 1-year survival)
- Secondary Outcome Measures
Name Time Method Response rate in patients with target lesions, CA19-9 response, distant metastasis-free survival, progression-free survival, adverse events, dose-intensity, treatment-related death, early death, grade 4 non-hematological toxicity