Actively Recruiting
CAPRI-3 GOIM Study: Phase 3 Trial Evaluating Continuing Cetuximab Treatment Beyond First-Line Progression in Molecular Selected Metastatic Colorectal Cancer Patients
Led by University of Campania Luigi Vanvitelli · Updated on 2026-02-05
480
Participants Needed
41
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether continuing cetuximab treatment beyond first-line progression can improve outcomes in adults with metastatic colorectal cancer who have tumors that are RAS and BRAF wild-type. This Phase 3 clinical trial aims to compare chemotherapy combined with cetuximab versus chemotherapy combined with bevacizumab, focusing on tumor response, progression-free survival, overall survival, and safety. The study builds on prior trials suggesting potential benefits of cetuximab continuation in this patient group. Participants will be randomly assigned to receive either FOLFOX or FOLFIRI chemotherapy combined with cetuximab (experimental group) or bevacizumab (control group). Treatments are given every two weeks, with cetuximab administered as a 120-minute intravenous infusion at 500 mg/m² and bevacizumab at 5 mg/kg. Therapy continues until disease progression, unacceptable side effects, or patient withdrawal. Tumor response will be assessed by independent review using RECIST criteria. During the study, patients undergo regular CT or MRI scans, laboratory tests, and clinical evaluations. Biological samples such as tumor tissue, blood, and stool are collected for research on resistance mechanisms and the gut microbiome. The primary measure is the overall response rate assessed up to 48 months, with secondary outcomes including overall survival, progression-free survival, and safety monitored throughout treatment and up to 30 days after the last dose. Participation lasts through treatment and follow-up periods up to several years.
CONDITIONS
Brief 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 of metastatic disease
- Major response or at least 6 months stable disease after first-line anti-EGFR therapy
- Disease progression after first-line therapy
- RAS and BRAF wild-type status confirmed by tissue and liquid biopsy
- PIK3CA, EGFR extracellular domain wild-type and HER2 not amplified
- Measurable disease per RECIST 1.1 criteria
- Male or female aged 18 years or older
- ECOG Performance Status 0-1
- Adequate bone marrow, liver, and renal function within 14 days before treatment
- Negative pregnancy test if female and of childbearing potential
- Agreement to use effective contraception during and 6 months after treatment
- Signed informed consent
You will not qualify if you...
- Contraindications to cetuximab, bevacizumab, irinotecan, 5-FU, oxaliplatin, or folic acid
- Active uncontrolled infections or certain blood clotting disorders
- History of other malignancies except certain treated skin and cervical cancers
- Pregnant or breastfeeding women
- Fertile individuals not agreeing to contraception
- Recent serious heart conditions or severe heart failure
- Arrhythmias needing anti-arrhythmic drugs except beta blockers or digoxin
- Medical or psychological conditions preventing consent or study conduct
- Participation in another clinical trial within 30 days
- Known or suspected brain metastases
- History of intestinal blockage, inflammatory bowel disease, or chronic diarrhea
- Severe non-healing wounds or bone fractures
- Significant proteinuria
- Known DPD deficiency
- History of alcohol or drug abuse
- Other significant diseases ruling out participation
- Restricted legal capacity
- Patients with dMMR or MSI-H tumors eligible for immune checkpoint inhibitors unless contraindicated or declined by patient
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From randomization until disease progression, unacceptable toxicity, or withdrawal of consent
Participants receive a second-line chemotherapy regimen (FOLFIRI or FOLFOX) combined with either cetuximab or bevacizumab. Treatment continues until disease progression, unacceptable toxicity, or withdrawal of consent.
Infusions every 14 days
Duration - Up to 36 months after randomization
Participants are monitored for survival and safety after treatment ends, including assessment of adverse events and overall survival.
Survival follow-up visits as scheduled up to 36 months
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
S
Stefania Napolitano
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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