A phase II study of adjuvant chemotherapy with 5-FU and heparin-based portal infusion chemotherapy followed by TS-1 for patients with resected pancreatic cancer (TOSPAC-02)
Phase 2
- Conditions
- Resected pancreatic cancer
- Registration Number
- JPRN-UMIN000013430
- Lead Sponsor
- Tokyo Study Group for Pancreatic Cancer (TOSPAC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria
Not provided
Exclusion Criteria
1) Pulmonary fibrosis or interstitial pneumonia 2) Uncontrolled pleural effusion 3) Resection of the distant organ metastasis 4) Active double cancer 5) Active infection 6) History of serious complications related to surgery 7) Active peptic ulcer 8) History of myocardial infarction within three months 9) Severe mental disorder 10) Pregnant or breast feeding 11) Patients judged inappropriate for the study by the physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease free survival Incidence of severe adverse events
- Secondary Outcome Measures
Name Time Method Overall survival Incidence of adverse events Proportion of treatment completion