Feasibility study of neoadjuvant mFOLFOX6 plus cetuximab in patients with resectable liver limited metastases from colorectal cancer harboring KRAS wild type

Feasibility study of neoadjuvant mFOLFOX6 plus cetuximab in patients with resectable liver limited metastases from colorectal cancer harboring KRAS wild type - FANTASTIC trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007545

Enrollment

Registered

2012-03-21

Start date

2012-03-01

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

Metastatic colorectal cancer

Interventions

mFOLFOX6 + cetuximab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients with histologically proven colorectal cancer (2)Resectable synchronous and metachronous liver metastases (3)Metastatic colorectal cancer with EGFR expressed (4)KRAS wild type in codon 12, 13 (5)Age over 20 years (6)ECOG Performance Status (PS) 0-1 (7)Presence of measurable lesion (RECIST Ver.1.1) (8)No prior chemotheray (9)Patiens have enough organ function for study treatment (10)Life expectancy of more than 3 months (11)Written informed consent

Exclusion criteria

Exclusion criteria: (1)Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval (2)Symptomatic brain metastases (3)Severe infectious disease (4)Interstitial lung disease or pulmonary fibrosis (5)Comorbidity or history of heart failure (6)Sensory alteration or paresthesia interfering with function (7)Severe comorbidity (renal failure, liver failure, hypertension, etc) (8)History of severe allergy (9)Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test

Design outcomes

Primary

Measure	Time frame
Treatment completion rate	—

Secondary

Measure	Time frame
Safety(CTCAE ver4.0), RR, Liver resectability, R0 rate, Postoperative complications, Explore the appropriate treatment duration from ICG (after 4 and 6 course) and CT	—

Countries

Japan

Contacts

Public ContactHideaki Bando

National Cancer Center Hospital East Department of Gastroenterology and Gastrointestinal Oncology

hbando@east.ncc.go.jp04-7133-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026