Prospective study for gemcitabine and S1 refractory pancreatic cancer with FOLFOX treatment

Prospective study for gemcitabine and S1 refractory pancreatic cancer with FOLFOX treatment - FOLFOX for GEM/S1 refractory pancreatic cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007875

Enrollment

Registered

2012-05-01

Start date

2012-05-01

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

unresectable or recurrent pancreatic cancer

Interventions

modified FOLFOX6 therapy against gemcitabine and S1 refractory pancreatic cancer

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed pancreatic adenocarcinoma 2. Unresectable or recurrent disease 3. Gemcitabine and S-1 refractory 4. Age over 20 5. ECOG PS=0, 1, 2 6. Life expectancy over 12 weeks 7. Well controlled sympton 8. Needs adequate organ function 9. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Uncontrollable diarrhea 2. Administration of phenytoin, warfarin, flucytosine 3. Pleural effusion, Ascites 4. Active serious infection 5. Active multiple cancer 6. Active peptic ulcer 7. Serious complication 8. Serious mental disorder 9. Serious drug allergy 10. Pregnancy woman, or woman with suspected pregnancy 11. Any subject judged by the investigator to be unfit for any reason to participate in the study

Design outcomes

Primary

Measure	Time frame
Feasibility (treatment continuation rate for 3 course) Overall survival	—

Secondary

Measure	Time frame
Response rate, Progression free survival, Adverse event	—

Countries

Japan

Contacts

Public ContactFuyuhiko Motoi

Tohoku University Hospital Division of hepato-biliary pancreatic surgery

fmotoi@surg1.med.tohoku.ac.jp022-717-7205

Outcome results

None listed

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