Evaluation of the standard therapy with FOLFIRI + Cetuximab until disease progression compared to FOLFIRI + Cetuximab for 8 cycles followed by Cetuximbab until disease progression in first line treatment of patients with RAS and BRAF wild type metastatic colorectal cancer.

ERbitux MEtastatic colorectal cancer Strategy Study: A phase III randomized two arm study with FOLFIRI + Cetuximab until disease progression compared to FOLFIRI + Cetuximab for 8 cycles followed by Cetuximab alone until disease progression in first line treatment of patients with RAS and BRAF wild type metastatic colorectal cancer.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004299-41-IT

Enrollment

600

Registered

2014-11-11

Start date

2014-12-24

Completion date

Unknown

Last updated

2023-09-11

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

Conditions

Patients with unresectable RAS and BRAF wild-type metastatic colorectal cancer. MedDRA version: 17.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864

Interventions

Trade Name: Erbitux Product Name: CETUXIMAB Pharmaceutical Form: Solution for infusion INN or Proposed INN: CETUXIMAB CAS Number: 205923-56-4 Concentration unit: mg/ml milligram(s)/millilitre Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histologically proven diagnosis of colorectal adenocarcinoma; - Diagnosis of metastatic disease; - RAS and BRAF wild-type; - Measurable disease according to RECIST criteria v1.1; - Male or female pts > 18 years of age; - ECOG Performance Status = 2; - Life expectancy of at least 3 months; - Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment; - If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment; - If female and of childbearing potential, or if male, agreement to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method); - Signed informed consent obtained at screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: - Any contraindication to use cetuximab, irinotecan, 5-FU or folinic acid - Active uncontrolled infections or active disseminated intravascular coagulation - Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix - Pregnancy. - Breastfeeding. - Grade III or IV heart failure (NYHA classification) - Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before inclusion in the study - Cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin - Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study - Previous chemotherapy for colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before entering the study - Participation in a clinical study or experimental drug treatment within 30 days prior to study inclusion or during participation in the study - Known or clinically suspected brain metastases - History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea - Severe, non-healing wounds, ulcers or bone fractures - Uncontrolled hypertension - Marked proteinuria (nephrotic syndrome) - Known DPD deficiency (specific screening not required) - Known history of alcohol or drug abuse - A significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study - Absent or restricted legal capacity

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether Cetuximab alone (given until progression or cumulative toxicity) after 8 cycles of FOLFIRI + Cetuximab results in a non-inferior Progression Free Survival when compared with continuous FOLFIRI + Cetuximab (given until progression or cumulative toxicity). The co-primary objective is to assess whether an improvement in the incidence of grade 3-4 adverse events can be achieved in the experimental arm as compared to the continuous chemotherapy arm. ;Secondary Objective: - Response Rate - Overall Survival - Quality of Life - To explore the possibility of using Liquid Biopsies for Molecular Profiling as well as monitoring treatment activity in mCRC pts receiving Cetuximab-based therapy ;Primary end point(s): Co-Primary: - Progression-free survival (PFS) - Incidence of grade 3-4 AEs ;Timepoint(s) of evaluation of this end point: Until progression	—

Measure

Time frame

Main Objective: To investigate whether Cetuximab alone (given until progression or cumulative toxicity) after 8 cycles of FOLFIRI + Cetuximab results in a non-inferior Progression Free Survival when compared with continuous FOLFIRI + Cetuximab (given until progression or cumulative toxicity). The co-primary objective is to assess whether an improvement in the incidence of grade 3-4 adverse events can be achieved in the experimental arm as compared to the continuous chemotherapy arm. ;Secondary Objective: - Response Rate - Overall Survival - Quality of Life - To explore the possibility of using Liquid Biopsies for Molecular Profiling as well as monitoring treatment activity in mCRC pts receiving Cetuximab-based therapy ;Primary end point(s): Co-Primary: - Progression-free survival (PFS) - Incidence of grade 3-4 AEs ;Timepoint(s) of evaluation of this end point: Until progression

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Secondary

Measure	Time frame
Secondary end point(s): Secondary: - Response rate - Early tumor shrinkage (8 weeks) - Overall survival - Cetuximab-related skin toxicity - Safety profile - Quality of life - Molecular profiles of tumor tissue and liquid biopsy - Potential predictive factors (somatic mutations identified in tumor tissue by next generation sequencing) and surrogate markers of treatment activity (changes in molecular profile of liquid biopsies);Timepoint(s) of evaluation of this end point: Until death	—

Measure

Time frame

Secondary end point(s): Secondary: - Response rate - Early tumor shrinkage (8 weeks) - Overall survival - Cetuximab-related skin toxicity - Safety profile - Quality of life - Molecular profiles of tumor tissue and liquid biopsy - Potential predictive factors (somatic mutations identified in tumor tissue by next generation sequencing) and surrogate markers of treatment activity (changes in molecular profile of liquid biopsies);Timepoint(s) of evaluation of this end point: Until death

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Countries

Italy, Spain

Contacts

Public ContactAntonino Amato

CTC Clinical Trial Center " A. Gemelli"

antonino.amato@unicatt.it00390630158762

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026