gastrointestinal cancer
Conditions
Interventions
Four cycles of modified FOLFOX7 therapy every 2 weeks. Treatment is started on the non-dialysis day, and dialysis continues even during continuous administration of 5-FU.
Sponsors
Kyoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients undergoing hemodialysis 2) Patients diagnosed as colorectal cancer. (It does not matter whether or not measurable lesion is present.) 3) 75 to 80 years old, and PS is 0-1. Or less than 75years old, and PS is 0-2. 4) Organ functions other than renal function are maintained. 5) Chemotherapy naive case. Postoperative adjuvant chemotherapy cases also qualify. 6) The written consent can be obtained.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [Part1] Rate of DLT [Part2] Rate of completing the protocol therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| [Part1] Adverse event [Part2] Adverse event, 1-year survival rate, PFS, response rate | — |
Countries
Japan
Contacts
Public ContactShigeki Kataoka
Graduate School of Medicine, Kyoto University Department of Therapeutic Oncology
Outcome results
None listed