BR-SIROX
- Conditions
- Pancreatic cancer
- Registration Number
- JPRN-jRCTs031180263
- Lead Sponsor
- Esaki Minoru
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
1 Borderline resectable pancreatic cancer
2 Adenocarcinoma or Adenosquamuscarcinoma
3 Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0 or 1
4 No treatment history of chemotherapy and chemoradiotherapy
5 No treatment history of chemotherapy and chemoradiotherapy for pancreatic cancer
6 No diarrhea
7 Orally ingestible
8 Appropriate biliary drainage in case of Obstructive jaundice
9 It has neither homozygote (UGT1A1 6/6,UGT1A1 28/28) nor double heterozygote (UGT1A1 6/28).
10 Adequate organ function
1 White blood cell less than 10.000/mm3
2 Neutrophil more than 1.500/mm3
3 Hemoglobin more than 9.0 g/dL
4 Platelet more than 10000/mm3
5 albumin more than 3.0g/dL
6 Total bilirubin less than 1.5mg/dL
7 AST less than 100U/L
8 ALT less than 100U/L
9 Serum creatinine less than 1.2mg/dL(Male), Serum creatinine less than 1.0mg/dL(Femal)
11 Written informed consent
12 Agree with operation
1 Multiple primary cancers with disease-free period less than 5 years
2 Active infection
3 Fever more than 38
4 Pregnant
5 Uncontrolled mental disease
6 Continuous administration of immunosuppressive drugs including steroids
7 Interstitial pneumonia
8 Serious complications
9 Unstable angina
10 Continuous administration of flucytosine, phenytoin, warfarin potassium
11 Allergy of contrast agent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method R0 Resection rate
- Secondary Outcome Measures
Name Time Method Relapse-free survival, Response rate, Overall survival, adverse events