Phase II study of FOLFIRI + cetuximab as induction chemotherapy followed by FOLFIRI + bevacizumab based on early tumor shrinkage in chemotherapy-naive patients with RAS wild-type colorectal cancer

Phase II study of FOLFIRI + cetuximab as induction chemotherapy followed by FOLFIRI + bevacizumab based on early tumor shrinkage in chemotherapy-naive patients with RAS wild-type colorectal cancer - Phase II study of FOLFIRI + cetuximab as induction chemotherapy followed by FOLFIRI + bevacizumab based on early tumor shrinkage in chemotherapy-naive patients with RAS wild-type colorectal cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023026

Enrollment

Registered

2016-08-01

Start date

2016-10-07

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

ETS was defined as 20% or more tumor reduction at 8 weeks. Patients with ETS after 8 weeks from the treatment start date continued FOLFIRI + Cmab as induction to 16 weeks, and switched to FOLFIRI +BV

Cetuximab: 250mg/m2day1 day1, 8(1cours day1:400mg/m2), CPT-11: 180mg/m2 day1, l-LV: 200mg/m2 day1, 5-FU bolus: 400mg/m2 day1, 5-FU infusion: 2400mg/m2 day1-2 FOLFIRI+BV maintenance therapy

Bevacizumab: 5mg/kg day1, CPT-11: 180mg/m2 day1, l-LV: 200mg/m2 day1, 5-FU bolus: 400mg/m2 day1, 5-FU infusion: 2400mg/m2 day1-2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven adenocarcinoma of colorectal cancer 2) Unresectable/recurrence colorectal cancer, no prior chemotherapy 3) RAS wild type 4) >= 20 years old 5) Measurable lesion according to RECIST (Ver.1.1) 6) ECOG performance status (PS) 0-2 7) Adequate organ function 8) Life expectancy of more than 90 days 9) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Previous treatment with irinotecan, bevacizumab, cetuximab/panitumumab 2) Symptomatic brain metastasis 3) Intestinal paralysis/obstruction 4) Massive pleural effusion, ascites, or pericardial effusion 5) Uncontrolled diarrhea 6) Active synchronous or metachronous malignancy 7) Severe infectious disease 8) Grade2 or higher skin toxicity 9) Interstitial pneumonia or pulmonary fibrosis 10) Serious complication(uncontrolled diabetes, severe cardiac disease, renal failure, liver failure) 11) History of thromboembolism 12) Unhealed wounds 13) Previous treatment with radiotherapy for primary disease 14) Administration of aspirin 15) Carcinomatous meningitis, uncontrolled epilepsy, mental disorder 16) Systemic administration of steroid 17) History of severe allergy 18) Positive for HBs antigen 19) Women who are pregnant or patients who are unwilling to avoid pregnancy 20) Patients who are inappropriate for the study in the opinion of the investigator

Design outcomes

Primary

Measure	Time frame
Progression free survival (PFS)	—

Secondary

Measure	Time frame
early tumor shrinkage(ETS) rate PFS of ETS positive and negative depth of response(DpR) Time to DpR time to treatment failure(TTF) response rate overall survival safety	—

Countries

Japan

Contacts

Public ContactTakashi Tsuda

St. Marianna University School of Medicine Department of Clinical Oncology

tatsuda@marianna-u.ac.jp044-977-8111

Outcome results

None listed

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