Phase II study of the combination of Oxaliplatin and 5FU(mFOLFOX6) in patients with unresectable advanced/recurrent small intestinal cancer

Phase II study of the combination of Oxaliplatin and 5FU(mFOLFOX6) in patients with unresectable advanced/recurrent small intestinal cancer - Phase II study of mFOLFOX6 in patients with unresectable advanced/recurrent small intestinal cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002797

Enrollment

Registered

2009-11-24

Start date

2010-03-01

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 advanced/recurrent small intestinal cancer

Interventions

mFOLFOX6

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed small intestinal cancer. 2.Unresectable/reccurent small intestinal cancer 3.PS is 0, 1 or 2 4.Over 20 years and under 80 years of age 5.Sufficient oral intake survival period 6.Adequate organ function 7.Wrtten informed consent

Exclusion criteria

Exclusion criteria: 1. Active other malignancies 2. Without assessable lesions 3. Active infectious disease 4. Peripheral neuropathy 5. Active Hemorrhage/bleeding 6. Uncontrollable watery diarrhea 7. Brain metastasis 8. Transfusion or blood product or growth factor such as G-CSF less than 7 days prior to entry 9. HBV carrier 10. Severe complications(ileus, interstitial pneumonitis, pulmonary fibrosis, uncontrollable diabetes mellitus, heart failure) 11. Pregnant or lactating woman 12. Severe psychological disease 13. Systemic steroid administration 14. Phenytoin, Warfarin potassium, or flucytosin administration 15. Not appropriate for the study at the physician's assessmnt

Design outcomes

Primary

Measure	Time frame
Progression-Free rate	—

Countries

Japan

Contacts

Public ContactTakahiro Horimatsu

Graduate School of Medicine, Kyoto University Department of Gastroenterology and Hepatology

thorimat@kuhp.kyoto-u.ac.jp075-751-3518

Outcome results

None listed

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