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

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 - 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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059294

Enrollment

110

Registered

2025-10-06

Start date

2025-05-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

unresectable colon cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
This study investigates the association between treatment efficacy (ORR, DCR, ETS, mTS, PFS, and OS) and tumor classification (LMCC or HMCC).	—

Countries

Japan

Contacts

Public ContactKota Ouchi

Tohoku University Hospital Medical Oncology

kota.ouchi.b3@tohoku.ac.jp022-717-8543

Outcome results