Retrospective study of distributions of FcGRIIa-131 and FcGRIIIa-158 polymorphisms and clinical response to cetuximab in metastatic colorectal cancer (mCRC)

Retrospective study of distributions of FcGRIIa-131 and FcGRIIIa-158 polymorphisms and clinical response to cetuximab in metastatic colorectal cancer (mCRC) - Fcgamma study in colorectal cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000004238

Enrollment

100

Registered

2010-09-30

Start date

2009-06-01

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

colorectal cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Adenocarcinoma confirmed histologically 2)Unresectable/metastatic colorectal cancer 3)KRAS genotype was examined 4)Baseline CT was done within 28 days from treatment 5)Measurable lesion 6)Treatment including cetuximab after September, 2008 7)5-FU resistant or intolerance 8)Irinotecan resistant or intolerance 9)Oxaliplatin resistant or intolerance 10)More than 20 years old 11)Gathering peripheral blood sample is possible 12)ECOG PS 0-2 13)Organs function is maintained 14)Informed consent by the document

Exclusion criteria

Exclusion criteria: (1)UGT1A1 genotype is homozygote of *28 or a homozygote of *6 or a double of *28 and *6 (Only cetuximab plus irinotecan therapy) (2)Serious infection (3)Drainage is nessesary(pleural effusion, ascites, pericardial effusion) (4)Intestinal pneumonia or the anamnesis and interstitial pulmonary fibrosis (5)Serious heart disease (6)Intestinal tract paralysis or ileus (7)Serious erethism (8)Serious complication (diabetes, high blood pressure, hypercalcaemia) (9)Brain metastasis with symptoms (10)Repetition cancer (11)Investigator judged to be inappropriate

Design outcomes

Primary

Measure	Time frame
Comparisons according to FcGR polymorphisms for progression-free survival	—

Secondary

Measure	Time frame
Comparisons according to FcGR polymorphisms for response rate and overall survival	—

Countries

Japan

Contacts

Public ContactHiraku Fukushima

Hokkaido University Hospital Department of Cancer Center

hirakuarata@gmail.com+81-11-716-1161

Outcome results