ROMANCE: "Irinotecan Plus Cetuximab Rechallenge Versus Trifluridine/Tipiracil Plus Bevacizumab in Molecularly Selected Metastatic Colorectal Cancer"
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This study is a phase II, open-label, multicenter clinical trial designed to evaluate two different treatment options for patients with metastatic colorectal cancer whose disease has progressed after standard therapies. The study compares a rechallenge treatment using irinotecan plus cetuximab with the current standard of care, trifluridine/tipiracil plus bevacizumab, as third-line therapy. Patients enrolled in the study are selected based on specific molecular characteristics of their cancer, identified through circulating tumor DNA analysis from a blood sample. The main purpose of the study is to determine whether the rechallenge with irinotecan and cetuximab leads to a higher tumor response rate compared with trifluridine/tipiracil plus bevacizumab. Secondary objectives include evaluating progression-free survival, overall survival, safety, and quality of life. Patients will be randomly assigned to one of the two treatment groups and will receive treatment until disease progression, unacceptable side effects, or withdrawal of consent. Tumor response will be assessed using standard imaging techniques according to RECIST criteria.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzony rozpoznaniem rak jelita grubego
- •Widoczny guz widoczny na badaniach obrazowych
- •Poprzednio leczony lekami anty-EGFR z odpowiedzią trwającą co najmniej 6 miesięcy
- •Wcześniej leczony drugim schematem terapii bez leków anty-EGFR
- •Przerwa co najmniej 4 miesiące od ostatniego leczenia anty-EGFR
- •Ogólny stan zdrowia pozwalający na uczestnictwo w badaniu
- •Prawidłowe wyniki badań krwi i funkcji wątroby oraz nerek
✗ Disqualifies
- •Poprzednie leczenie lekiem trifluridyna/tipiracil
- •Jakiekolwiek przeciwwskazania do leków stosowanych w badaniu
- •Kobieta w wieku rozrodczym bez możliwości zapobiegania ciąży podczas badania
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 11, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (26)
Azienda Ospedaliero Universitaria "SS Antonio e Biagio e Cesare Arrigo"
Alessandria, Italy
A.O.U. Ospedali Riuniti
Ancona, Italy
Centro di Riferimento Oncologico (CRO), IRCCS
Aviano, Italy
A.O.R.N. "Sant'anna e San Sebastiano"
Caserta, Italy
Ospedale IRCCS 'Saverio de Bellis'
Castellana Grotte, Italy
A.R.N.A.S. Garibaldi - P.O. Garibaldi-Nesima
Catania, Italy
Azienda Ospedaliero-Universitaria Renato Dulbecco
Catanzaro, Italy
A.O.U. Careggi
Florence, Italy
Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori'
Meldola, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Fondazione IRCCS Istituto Nazionale Tumori
Milan, Italy
Istituto Europeo di Oncologia
Milan, Italy
Casa di Cura Villa Maria
Mirabella Eclano, Italy
AOU Policlinico di Modena
Modena, Italy
A.O.U. dell'Università degli studi della Campania "Luigi Vanvitelli"
Naples, Italy
Istituto Nazionale Tumori 'Fondazione G. Pascale'
Naples, Italy
Istituto Oncologico Veneto IRCCS
Padova, Italy
ARNAS Civico - Di Cristina-Benfratelli - P. O. 'Civico e Benfratelli'
Palermo, Italy
Casa di cura Macchiarella
Palermo, Italy
A.O.U. Pisana
Pisa, Italy
Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS
Roma, Italy
Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
A.O.U. Sassari
Sassari, Italy
Ospedale San Giuseppe Moscati
Statte, Italy
A.O. 'Pia Fondazione Cardinale G. Panico'
Tricase, Italy
ASST Sette Laghi-Ospedale di Circolo Fondazione Macchi
Varese, Italy
Trial contact
Davide Ciardiello DC Principal Investigator
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/12/2026.
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