Japanese trial -A Global Study To Evaluate The Potential Benefit of Adjuvant Chemotherapy for Small Bowel Adenocarcinoma (JCOG1502C, J-BALLAD)
- Conditions
- small bowel adenocarcinoma
- Registration Number
- JPRN-UMIN000027280
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
Not provided
1) Synchronous or metachronous (within 5 years) malignancies 2) Active infection requiring systemic therapy. 3) Body temperature of 38 degrees Celsius or higher. 4) Female during pregnancy, within 28 days of postparturition, or during lactation. 5) Severe psychological disease. 6) Continuous systemic corticosteroid or immunosuppressant treatment. 7) Inflammatory bowel disease (ex. Crohn disease, ulcerative colitis) or malabsorption (ex. Celiac disease) requiring therapy. 8) Uncontrollable diabetes mellitus 9) Uncontrollable hypertension 10) Unstable angina pectoris, or history of myocardial infarction within 6 months. 11) Positive HIV antibody. 12) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest CT.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse-free survival
- Secondary Outcome Measures
Name Time Method overall survival, disease-free survival (DFS defined by JCOG), disease-free survival (DFS defined by IRCI), adverse events