Randomized trial of oxaliplatin plus S-1 (SOX) versus S-1 alone in patients with gemcitabine-refractory pancreatic cancer
Phase 3
- Conditions
- Gemcitabine-refractory pancreatic cancer
- Registration Number
- JPRN-jRCT2080220660
- Lead Sponsor
- Yakult Honsha Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
Histologically or cytologically proven pancreatic adenocarcinoma or adenosquamous carcinoma
Gemcitabine refractory
Taking orally
ECOG performance status (PS) :0-1
Measurable metastatic disease based on RECIST criteria
Exclusion Criteria
Prior treatment with platinum- or fluoropyrimidine -agent
Prior treatment with radiotherapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival (PFS)<br>To verify the superiority of SOX to S-1 alone in PFS
- Secondary Outcome Measures
Name Time Method Overall survival, response rate, safety