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Feasibility and potential benefits of preoperative chemotherapy with Gemcitabine+nab/Paclitaxel in patients with resectable pancreatic cancer: a multicenter phase I/II trial (APCS-01 study).

Phase 1
Conditions
resectable pancreatic cancer
Registration Number
JPRN-UMIN000033901
Lead Sponsor
Hirosaki University Graduate School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

1. Patient with the treatment history of gemcitabine or nab/paclitaxel. 2. R0 resection is judged to be impossible. 3. Patient with sever diarrhea. 4. Patient with sever ascites and pleural effusion. 5. Patient with active other cancer. 6. Patient with sever coexisting disease. 7. Patients with active infectious disease. 8. Patient with remarkable abnormal electrocardiogram or sever cardiac disorder. 9. Patient with severe psychiatric disorder. 10. Pregnant female, lactating female, female who might be pregnant, female who hopes to be pregnant, and male who hopes the partner's pregnancy. 11. Patient with the history of sever medication allergy. 12. Patient with continuous systemic administration of the steroid. 13. Patient with contraindication of gemcitabine and nab-paclitaxel. 14. Patient where the attending doctor judged unsuitable for safely carrying out.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
relapse-free survival time
Secondary Outcome Measures
NameTimeMethod
completion rate of preoperative chemotherapy, over-all survival time, down-staging rate, R0 resection rate, adverse event rate, anti-tumor efficacy
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