Actively Recruiting
Continuation of Cetuximab Beyond First-Line Progression in Metastatic Colorectal Cancer
Led by University of Campania Luigi Vanvitelli · Updated on 2026-02-05
480
Participants Needed
41
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this Phase 3 clinical trial is to evaluate whether continuing cetuximab treatment beyond first-line progression can improve outcomes in patients with metastatic colorectal cancer whose tumors are RAS and BRAF wild-type. The study will compare the effectiveness of chemotherapy given together with cetuximab versus chemotherapy given together with bevacizumab. Researchers aim to determine whether cetuximab continuation improves tumor response, progression-free survival, overall survival, and safety in this patient population. Eligible participants are adults with metastatic colorectal cancer who have previously responded to first-line treatment with chemotherapy combined with an anti-EGFR antibody. Before starting therapy, patients will undergo molecular testing using liquid biopsy to confirm tumor characteristics. They will then receive chemotherapy with either cetuximab or bevacizumab every two weeks, and their disease will be monitored regularly with CT or MRI scans, laboratory tests, and clinical evaluations. During the study, patients will also provide biological samples for translational research. This trial will enroll about 360 patients across sites in Italy and Spain and is designed to provide new evidence on whether cetuximab continuation beyond first-line treatment can offer a meaningful clinical benefit compared with standard therapy.
CONDITIONS
Official Title
Continuation of Cetuximab Beyond First-Line Progression in Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed colorectal adenocarcinoma diagnosis
- Diagnosis of metastatic disease
- Major response or prolonged stable disease (at least 6 months) after first-line therapy with anti-EGFR drug
- Disease progression after first-line therapy
- RAS and BRAF wild-type status confirmed by tissue analysis
- RAS (NRAS and KRAS exon 2,3,4), BRAFV600E, PIK3CA, EGFR extracellular domain wild-type, and HER2 non-amplified by liquid biopsy at screening
- Measurable disease by RECIST 1.1 criteria
- Male or female aged 18 years or older
- ECOG Performance Status 0-1
- Adequate bone marrow, liver, and kidney function within 14 days before treatment
- Negative pregnancy test if female of childbearing potential within 7 days before treatment
- Agreement to use adequate contraception during study and for 6 months after treatment
- Signed informed consent obtained before screening
You will not qualify if you...
- Contraindications to cetuximab, bevacizumab, irinotecan, 5-FU, oxaliplatin, or folic acid
- Uncontrolled infections, disseminated intravascular coagulation, or history of interstitial lung disease
- Other malignancies except treated basal/squamous skin cancer or in situ cervical carcinoma
- Pregnancy or breastfeeding
- Fertile women and men not willing to use effective contraception
- Recent serious heart conditions or heart failure NYHA Grade III or IV
- Cardiac arrhythmias requiring treatment except beta blockers or digoxin
- Medical or psychological conditions limiting consent or study participation
- Participation in other clinical studies within 30 days prior or during
- Known or suspected brain metastases
- History of intestinal occlusion, chronic inflammatory bowel disease, or chronic diarrhea
- Severe non-healing wounds, ulcers, or bone fractures
- Marked proteinuria (nephrotic syndrome)
- Known DPD deficiency
- History of alcohol or drug abuse
- Significant other diseases precluding participation
- Restricted legal capacity
- Patients with dMMR or MSI-H tumors eligible for immune checkpoint inhibitors unless contraindicated or declined by patient
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Trial Site Locations
Total: 41 locations
1
A.O.U. Ospedali Riuniti
Ancona, Italy
Not Yet Recruiting
2
AORN S. Giuseppe Moscati
Avellino, Italy
Not Yet Recruiting
3
Centro di Riferimento Oncologico (C.R.O.) IRCCS
Aviano, Italy
Not Yet Recruiting
4
IRCCS Istituto Tumori "Giovanni Paolo II"
Bari, Italy
Not Yet Recruiting
5
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy
Not Yet Recruiting
6
Ospedale IRCCS 'Saverio de Bellis'
Castellana Grotte, Italy
Not Yet Recruiting
7
Nome EnteA.R.N.A.S. Garibaldi - P.O. Garibaldi-Nesima
Catania, Italy
Not Yet Recruiting
8
Azienda Ospedaliero-Universitaria Renato Dulbecco
Catanzaro, Italy
Not Yet Recruiting
9
A.O.U. Careggi
Florence, Italy
Not Yet Recruiting
10
P.O. 'Vito Fazzi'
Lecce, Italy
Not Yet Recruiting
11
Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori'
Meldola, Italy
Not Yet Recruiting
12
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Not Yet Recruiting
13
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Not Yet Recruiting
14
Istituto Europeo di Oncologia
Milan, Italy
Not Yet Recruiting
15
Casa di Cura Villa Maria
Mirabella Eclano, Italy
Not Yet Recruiting
16
A.O.U. dell'Università degli studi della Campania 'Luigi Vanvitelli'
Naples, Italy
Actively Recruiting
17
A.O.U. Federico II
Naples, Italy
Not Yet Recruiting
18
IRCCS I.N.T. 'Fondazione G. Pascale'
Naples, Italy
Not Yet Recruiting
19
Istituto Oncologico Veneto IRCCS
Padova, Italy
Not Yet Recruiting
20
ARNAS Civico - Di Cristina-Benfratelli - P. O. 'Civico e Benfratelli'
Palermo, Italy
Not Yet Recruiting
21
Casa di cura Macchiarella
Palermo, Italy
Not Yet Recruiting
22
A.O.U. Pisana
Pisa, Italy
Not Yet Recruiting
23
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, Italy
Not Yet Recruiting
24
Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS
Roma, Italy
Not Yet Recruiting
25
IRCCS Istituto clinico Humanitas
Rozzano, Italy
Not Yet Recruiting
26
Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
Not Yet Recruiting
27
A.O.U. Sassari
Sassari, Italy
Not Yet Recruiting
28
Ospedale San Giuseppe Moscati
Statte, Italy
Not Yet Recruiting
29
A.O. 'Pia Fondazione Cardinale G.Panico'
Tricase, Italy
Not Yet Recruiting
30
IRCCS Ospedale Sacro Cuore Don Calabria
Veneto, Italy
Not Yet Recruiting
31
Hospital del Mar
Barcelona, Spain
Not Yet Recruiting
32
Hospital Universitari Vall d´Hebron
Barcelona, Spain
Not Yet Recruiting
33
Hospital General Universitario Santa Lucía
Cartagena, Spain
Not Yet Recruiting
34
Hospital Universitario Reina Sofía
Córdoba, Spain
Not Yet Recruiting
35
Hospital Universitario Virgen de las Nieves
Granada, Spain
Not Yet Recruiting
36
Instituto Catalán de Oncología. Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain
Not Yet Recruiting
37
Hospital Universitario 12 de Octubre
Madrid, Spain
Not Yet Recruiting
38
Hospital Universitario Gregorio Marañón
Madrid, Spain
Not Yet Recruiting
39
Hospital Universitario Regional de Málaga
Málaga, Spain
Not Yet Recruiting
40
Hospital Universitario de Navarra
Pamplona, Spain
Not Yet Recruiting
41
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Not Yet Recruiting
Research Team
F
Fortunato Ciardiello
CONTACT
S
Stefania Napolitano
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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