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

Not Applicable

• Conditions: colorectal cancer; RAS BRAF PSSkit sysmex; D015179

• Registration Number: JPRN-jRCT1050210160
• Lead Sponsor: Kataoka Kozo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to RAS mutations acquired

Secondary Outcome Measures

Name	Time	Method
Correlation between time to RAS mutations acquired and disease progression, frequencies of BRAF/PIK3CA mutations in ctDNA, disease free survival and overall survival