Phase II study of the combination of Oxaliplatin and 5FU(mFOLFOX6) in patients with unresectable advanced/recurrent small intestinal cancer
- Conditions
- unresectable advanced/recurrent small intestinal cancer
- Registration Number
- JPRN-UMIN000002797
- Lead Sponsor
- Graduate School of Medicine, Kyoto University
- Brief Summary
Between April 2010 and November 2012, 24 patients were enrolled from 12 institutions. Median age: 63 years old (range, 31–79); male/female ratio: 18/6; PS 0: 17 (71%); PS 1: 7 (29%); locally advanced/metastatic disease: 2/22; primary tumor site: duodenum (58%) and jejunum (42%). The median follow-up time was 14.7 months (3.7-40.3). The 1-year PFS was 23.3%. The ORR was 45% (9/20). The median PFS and OS were 5.9 months (95% CI, 3.0–10.2) and 17.3 months (95% CI, 11.7–19.0), respectively. The common grade 3 or 4 toxicities were neutropenia (38%), anemia/peripheral neuropathy (25%), stricture (17%), fatigue/anorexia/bilirubin increase (8%), and diarrhea (4%). There were no treatment-related deaths.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-Free rate
- Secondary Outcome Measures
Name Time Method