Prep-03
Phase 1
Recruiting
- Conditions
- Pancreatic cancerpancreatic cancerC535836
- Registration Number
- JPRN-jRCTs021180045
- Lead Sponsor
- nno Michiaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
1) invasive ductal carcinoma of the pancreas
2) no distant metastasis
3) R0/1 resectable
4) borderline resectable Pancreatic cancer
5) all adult who anticipate to undergo pancreatectomy
6) no prior therapy
7) ECOG performance status of 0 or 1
8) adequate organ function
9) oral intake is possible
10) written informed consent
Exclusion Criteria
1) pulmonary fibrosis or interstitial pneumonitis
2) Active double cancer
3) Active infection
4) HBs antigen positive
5) patients are using flucytosine, phenytoin, warfarin
6) pregnant females, possibly pregnant females
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MTD RTD
- Secondary Outcome Measures
Name Time Method R0 resection ratio<br>Safety<br>Histological effect<br>Treatment completion rate<br>Lymph node metastasis rate<br>Tumor marker reduction rate - Tumor marker normalization rate after resection<br>2-year survival rate<br>Overall survival rate