Observational study of hand-foot syndrome events from XELOX therapy for metastatic colorectal cancer.
- Conditions
- metastatic colorectal cancer
- Registration Number
- JPRN-UMIN000007185
- Lead Sponsor
- Fujita Health University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
1.Pleural effusion, peritoneal fluid and pericardial fluid. 2. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ. 3. Serious drug hypersensitivity or a history of drug allergy for Fluorouracil, leucovorin calcium or platinum agents. 4. Dihydropyrimidine Dehydrogenase Deficiency. 5. Evidence of interstinal lung disease, or pulmonary fibrosis. 6. Uncontrolled Active infection. 7. Difficulty on oral intake. 8. Other conditions not suitable for this study 9. Symptomatic brain metastasis. 10. Complication of cerebrovascular disease or symptoms within 1 year. 11. Any surgical treatments including skin open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week. 12. Planned surgery during this study. 13. Administering antithrombotic drug within 10 days. 14. Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDs). 15. Evidence of bleeding diathesis or coagulopathy. 16. Active gastrointestinal ulcer. 17. Renal failure to be treated, 2+ or higher proteinuria within 2 weeks prior to entry. 18. Uncontrolled Hypertension. 19. Clinically significant (i.e. active) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HFS (> grade 2) events rate for classification of Blum
- Secondary Outcome Measures
Name Time Method Evaluation of QOL: 1) HADS (Hospital Anxiety and Depression Scale) 2)MAC (Mental Adjustment to Cancer)