Colorectal Cancer
Conditions
Interventions
Patients receive modified FOLFOX6 with bevacizumab (Treatment will be continued to 24 cycles unless the disease progression, unacceptable toxicity, or consent withdrawal.).
Sponsors
Yakult Honsha Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed adenocarcinoma of the colon or rectum. 2.Unresectable or recurrent colorectal cancer patient. 3.At least one unidimensionally measurable lesion. 4.No prior chemotherapy, immunotherapy, and radiotherapy. 5.Aged 20<= years. 6.Eastern Cooperative Oncology Group (ECOG) performance status of 1>=. 7.Life expectancy at least 3 months. 8.Adequate bone marrow, heart, pulmonary, liver, and renal function. 9.Written informed consent
Exclusion criteria
Exclusion criteria: Patient with contraindication to oxaliplatin, 5-FU, l-LV, or Bevacizumab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Progression free survival:PFS,Time to treatment failure:TTF,Time to failure of strategy:TFS,Overall survival:OS,Safety: Adverse events, Duration of peri-pheral neuropathyBiomarker, such as genomic, proteomic, and metabolomic expression, profiling to discriminate the response to the treatment from patients' blood samples. | — |
Countries
Japan
Contacts
Public ContactHirohiko Maeda
Yakult Honsha Co.,Ltd. Pharmaceutical Development Department, Post Marketing Development Section
Outcome results
None listed