Observational Study of RAS monitoring for RAS/BRAF wild advanced Colorectal Cancer Patients treated with anti EGFR antibody

JRCT ID: jRCT1050210160

Registered date:22/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: colorectal cancer
• Date of first enrollment: 08/01/2022
• Target sample size: 40
• Study type: Observational

Outcome(s)

• Primary Outcome: Time to RAS mutations acquired
• Secondary Outcome: Correlation between time to RAS mutations acquired and disease progression, frequencies of BRAF/PIK3CA mutations in ctDNA, disease free survival and overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Histologically proven for colorectal cancer
2)Clinical Stage III/IV 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)No previous history of chemotherapy and radiotherapy
5)Aged 20 years old and over
6)ECOG PS0-1
7)Consent for blood exam for ctDNA analy
8)Written informed consent

Exclude criteria

1)Active other malignancies
2)Pregnancy, possible pregnancy or breastfeeding
3)Severe pulmonary fibrosis or emphysema
4)Psychiatric disease
5)Patients requiring systemic steroid medication
6) Grade 2 or greater diarrhea or sensory neuropathy
7)Poorly controlled hypertension
8)History of severe heart disease, heart failure, unstable angina within 6 months or angina attack with 6 months
9) active COVID-19 infection

Related Information

• Primary Sponsor: Kataoka Kozo