Feasibility study of Pre-operative FOLFIRI3 plus cetuximab for KRAS wild type resectable advanced colorectal cancer (mCRC).

Feasibility study of Pre-operative FOLFIRI3 plus cetuximab for KRAS wild type resectable advanced colorectal cancer (mCRC). - Pre-operative FOLFIRI3 plus cetuximab study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009630

Enrollment

Registered

2013-01-01

Start date

2013-01-09

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

Resectable advanced colorectal cancer

Interventions

Pre-operative chemotherapy(FOLFIRI3 plusCetuximab)4cycles =&gt

To evaluate effect =&gt

Surgical resection or Continued chemotherapy =&gt

Surgical resection. *FOLFIRI3 plus Cetuximab Cetuximab500 mg/m2/day1/q2w CPT-11 100 mg/m2/day1,3/q2w I-LV 200 mg/m2/day1/q2w 5-FU/infusional 2400 mg/m2/46hr/q2w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed colorectal cancer. 2) KRAS wild type in codon 12, 13. 3) A measurable lesion or an evaluable lesion is confirmed with an objectivity document according to RECIST standard. 4) Resectable metastatic colorectal cancer 5) No prior chemotherapy. 6) Age over 20 years. 7) ECOG Performance Status 0-2. 8) Adequate organ function for study treatment. 9) A life expectancy of more than 3 months. 10) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval. 2) Patients who have brain metastases. 3) Severe myelosuppression. 4) Severe infections. 5) Patients who have interstitial pneumonitis or past histories of interstitial pneumonitis and/or pulmonary fibrosis. 6) Severe heart failure or past histories of heart failure. 7) Sever dysfunctional paresthesia or dysesthesia. 8) Patient who have massive cancer-malignant effusion (e.g, pleural effusion, ascites, pericardial effusion) 9) Severe complications (e.g.,renal failure, hepatic failure or high blood pressure ). 10) Patient who have intestinal paralysis or bowel obstruction . 11) Patient who have jaundice. 12) Patients who have given a dose of atazanavir sulfate. 13) Pregnant woman, nursing mothers, possibly pregnant woman and wishing to become pregnant. 14) History of severe allergy. 15) Patient who have given Cetuximab or CPT-11before enrollment. 16) The Patient that a study responsibility physician judged to be inappropriate.

Design outcomes

Primary

Measure	Time frame
Treatment completion rate	—

Secondary

Measure	Time frame
Tumor reduction rate(4cycles & 8cycle),Response rate, Histological therapeutic effect,safety,Postoperative complication	—

Countries

Japan

Contacts

Public ContactHideaki Miyauchi

Chiba graduate school of medicine Department of frontier surgery

miyahide@faculty.chiba-u.jp043-226-2110

Outcome results

None listed

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