unresectable or recurrent small bowel adenocarcinoma with no prior treatment none
Conditions
Interventions
CapeOX regimen to give only by participating only in this clinical trial
none
Sponsors
Yasui Hirofumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed unresectable or recurrent small bowel adenocarcinoma 2) Prior chemotherapy, radiotherapy, chemoradiotherapy, hormonal therapy were not allowed, but prior use of adjuvant chemotherapy at least 6 months before evidence of recurrence was permitted 3) Age over 20 years 4) ECOG Performance status (PS) 2 or less (if age >= 75 years, PS 1 or less) 5) No symptomatic CNS metastasis 6) Adequate organ functions 7) No clinically abnormal findings in 12-lead resting [- within 28 days before enrollment 8) Adequate oral intake 9) Have an estimated life expectancy of over 3 months after enrollment 10) Available written informed consent 11) Having evaluable evaluable lesions
Exclusion criteria
Exclusion criteria: 1) Intolerance of capecitabine and oxaliplatin 2) Females who are in pregnancy, breastfeeding, with a positive pregnancy test or unwilling to use adequate contraception or males of reproductive potential 3) With receiving treatment for active infections or with fever (body temperature >=38degc) infectious disease is doubted 4) Intestinal paralysis, gastrointestinal obstruction, or uncontrolled diarrhea 5) with paresis of intestine, bowel obstruction, or uncontrolled diarrhea (diarrhea interfering daily life under treatment) 6) with serious complications (interstitial pneumonia or pulmonary fibrosis, heart failure, renal failure, liver failure, uncontrolled hypertension or diabetes mellitus, etc.) 7) With severe paresthesia dysfunction 8) With other active cancer 9) need continuous treatment with phenytoin or warfarin potassium 10) receiving systemic treatment with corticosteroids 11) Patients whom primary physicians deems are not appropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year progression-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, overall survival, response rate, safety | — |
Contacts
Public ContactTakeshi Kawakami
Shizuoka Cancer Center
Outcome results
None listed