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Randomized trial of oxaliplatin plus S-1 (SOX) versus S-1 alone in patients with gemcitabine-refractory pancreatic cancer

Randomized trial of oxaliplatin plus S-1 (SOX) versus S-1 alone in patients with gemcitabine-refractory pancreatic cancer

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220660
Enrollment
240
Registered
2009-01-23
Start date
2009-01-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gemcitabine-refractory pancreatic cancer

Interventions

investigational material(s) Generic name etc : Oxaliplatin and S-1 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigation

Sponsors

Yakult Honsha Co.,Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Prior treatment with platinum- or fluoropyrimidine -agent Prior treatment with radiotherapy

Design outcomes

Primary

MeasureTime frame
Progression free survival (PFS) To verify the superiority of SOX to S-1 alone in PFS

Secondary

MeasureTime frame
Overall survival, response rate, safety

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026