The multicenter clinical trial to investigate the safety and efficacy of FOLFOX therapy in gastrointestinal cancer patients undergoing hemodialysis
Not Applicable
Recruiting
- Conditions
- gastrointestinal cancer
- Registration Number
- JPRN-UMIN000033322
- Lead Sponsor
- Kyoto University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Not provided
Exclusion Criteria
1) Hyperammonemia within 14 days before registration. 2) Peripheral sensory neuropathy Grade 2 (evaluated in CTCAE v 4.0) or more. 3) Oral administration of warfarin is necessary. 4) During peritoneal dialysis. 5) Cirrhosis (Child-Pugh B, C) 6) Symptoms that suspect encephalopathy such as gait disturbance and language disorder. 7) Patients refused to participate in this study. 8) The doctor judged inappropriate to register for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [Part1] Rate of DLT [Part2] Rate of completing the protocol therapy
- Secondary Outcome Measures
Name Time Method [Part1] Adverse event [Part2] Adverse event, 1-year survival rate, PFS, response rate