P II study of CapeOX therapy for small intestinal cancer

JRCT ID: jRCTs041180011

Registered date:06/11/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: unresectable or recurrent small bowel adenocarcinoma with no prior treatment
• Date of first enrollment: 07/07/2020
• Target sample size: 17
• Study type: Interventional
• Intervention(s): CapeOX regimen to give only by participating only in this clinical trial

Outcome(s)

• Primary Outcome: 1 year progression-free survival rate
• Secondary Outcome: progression-free survival, overall survival, response rate, safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Yasui Hirofumi