Tokyo, Oct. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059294) titled 'A biomarker study associated with a randomized, prospective phase II trial comparing the efficacy and safety of mFOLFOX6 plus cetuximab (q2w) versus mFOLFOX6 plus bevacizumab as first-line treatment for unresectable right-sided colon cancer with RAS/BRAF wild-type' on Oct. 6.

Study Type: Observational

Primary Sponsor: Institute - JR Sendai Hospital

Condition: Condition - unresectable colon cancer Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - As a specified clinical research study, this project aims to investigate the relationship between treatment efficacy or resistance mechanisms and the DNA methylation status as well as gene mutation profiles measured using ctDNA in patients with right-sided colon cancer who received mFOLFOX6 plus bevacizumab or mFOLFOX6 plus cetuximab as first-line chemotherapy. Basic objectives2 - Others

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients with a primary tumor located in the right colon (cecum, ascending colon, or transverse colon) histologically diagnosed as colorectal adenocarcinoma. Patients with metastatic colorectal cancer (Stage IV according to the UICC TNM classification) or postoperative recurrent colorectal cancer. Confirmed RAS (KRAS and NRAS) wild-type status based on genetic testing. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. Presence of at least one measurable target lesion on imaging, as defined by RECIST version 1.1. Key exclusion criteria - Presence of a confirmed BRAF V600E mutation. Patients with brain metastases or those with a strong clinical suspicion of brain metastases. Patients with effusions requiring intervention, such as pleural effusion, ascites, or pericardial effusion. Patients with a history of interstitial lung disease, or those with extensive findings suggestive of such conditions on CT imaging. Target Size - 110

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 05 Month 05 Day Date of IRB - 2025 Year 04 Month 18 Day Anticipated trial start date - 2025 Year 05 Month 31 Day Last follow-up date - 2028 Year 05 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067823

Disclaimer: Curated by HT Syndication.