colorectal cancer RAS BRAFwild coloretal cancer
Conditions
Interventions
None listed
Sponsors
Kozo Kataoka
Sysmex
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically proven for colorectal cancer 2)Clinical Stage IV or recurrent colorectal cancer for which more than 12 cycles of chemotherapy including anti-EGFR therapy is planned. 3)measurable lesions according to RECIST ver1.1 4)Presence of liver metastases 5) No previous history of chemotherapy and radiotherapy 6)Aged 20 years old and over 7)ECOG PS0-1 8)Consent for blood exam for ctDNA analy 9)Written informed consen
Exclusion criteria
Exclusion criteria: 1)Active other malignancies 2)Histologically confirmed for MMRD (MSI-H or dMMR) 3)Pregnancy, possible pregnancy or breastfeeding 4)Severe pulmonary fibrosis or emphysema 5)Psychiatric disease 6)Patients requiring systemic steroid medication 7) Grade 2 or greater diarrhea or sensory neuropathy 8)Poorly controlled hypertension 9)History of severe heart disease, heart failure, unstable angina within 6 months or angina attack with 6 months 10) active COVID-19 infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival in ctDNA RAS/BRAF wild and mutant | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate in ctDNA RAS/BRAF wild and mutant, overall survival, adverse event, frequency of ctDNA mutant, exploratory analysis of registant genes for anti EGFR therapy, frequency of RAS/BRAF ctDNA mutant when patients are refractory for anti-EGFR therapy, integrated analysis with RAS-trace 1, response rate, progression-free survival and overall survival in left-sided colorectal cancer patients with ctDNA RAS/BRAF wild and mutant, and response rate, progression-free survival and overall survival in colorectal cancer liver metastases with ctDNA RAS/BRAF wild and mutant, | — |
Contacts
Public ContactMai Fujimori
Hyogo Medical University Hospital
Outcome results
None listed