Phase2 trial of oxaliplatin, irinotecan and S-1 (OX-IRIS) as first line chemotherapy for unresectable pancreatic cancer
- Conditions
- pancreatic cancer
- Registration Number
- JPRN-jRCTs011190008
- Lead Sponsor
- Komatsu Yoshito
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
1. Histologically proven adenocarcinoma or adenosquamous carcinoma of the advanced or recurrent pancreatic cancer
2. With measurable disease (RECIST v1.1)
3. aged 20 to 75 years old
4. ECOG PS 0 or 1
5. No prior chemotherapy or radiation therapy (in case of previous neoaduvant therapy, interval from operation and relapse must be >6 months, and in case of previous adjuvant therapy, interval from end of chemotherapy and relapse must be >6 months for S-1 therapy)
6. Expected life span >= 8 weeks
7. Ingestible
8. Hematological status: neutrophils(ANC)>=1.5x109/L; platelets >=100x109/L; haemoglobin >=9g/dL, Adequate renal function: serum creatinine level >=1.2mg/dl, Ccr >=60mL/min, Adequate liver function: serum bilirubin <=2.0 x upper normal limit(ULN), AST/ALT< 2.5 x the ULN for the reference lab
9.Signed and dated informed consent
1. Active double cancer
2. UGT1A1 double hetero(UGT1A1*6/*28) or homo(UGT1A1*6 or UGT1A1*28)
3. Neuropathy with symptoms
4. blood transfusions within 7 days from registration
5. severe pleural effusion or ascites
6. Watery diarrhea
7. Severe complication
8. Infectious disease
9. Active viral hepatitis
10. Brain metastasis with clinical symptoms
11. systemic steroid use
12. Persons to be pregnant or to make pregnant
13. Contraindication to oxaliplatin, Irinotecan, and S-1
14. Participation in the clinical trial is determined as unsuitable.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method progression free survival<br>overall survival<br>safety<br>dose intensity