Phase I study of third-line FOLFIRINOX (oxaliplatin, irinotecan, 5-FU, and leucovorin) unresectable Gem/S-1 refractory pancreatic adenocarcinoma
- Conditions
- unresectable Gem/S-1 refractory pancreatic adenocarcinoma
- Registration Number
- JPRN-UMIN000021526
- Lead Sponsor
- Osaka Medical Center for Cancer and Cardiovascular Diseases Division of Hepatobiliary and Pancreatic Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
1. Poorly controlled ascites 2. Patients homozygous for UGT1A1*6 or UGT1A1*28, or double heterozygotes (*6/*28) 3. Active infection 4. Lung fibrosis or intestinal pneumonia detectable on chest X-ray and CT 5. Severe complication (heart disease, cirrhosis, diabetes) 6. Myocardial infarction within 3 months 7. Active synchronous or metachronous malignancy, excluding intramucosal carcinoma 8. Pregnant or lactation women, or women with known or suspected pregnancy 9. Symptomatic brain metastasis 10. history of severe drug allergy 11. Grade 2 or higher peripheral sensory neuropathy 12. Impossible to implant the central venous port 13.Patients who are judged inappropriate for the entry into the study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method occurrence of side effect of preoperative gemcitabine based chemoradiation therapy
- Secondary Outcome Measures
Name Time Method Response Rate, Overall Survival (OS) , Progression free survival (PFS)