Spots Global Cancer Trial Database for CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen
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Trial Identification
Brief Title: CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen
Official Title: CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio- Marker-driven Cetuximab-based Treatment Regimen Over 3 Treatment Lines in mCRC Patients With RAS/BRAF wt Tumors at Start of First Line
Study ID: NCT05312398
Conditions
Study Description
Brief Summary: This clinical program aims to evaluate the activity and efficacy of cetuximab continuation of treatment for three lines of therapy with rotation of chemotherapy (FOLFIRI, FOLFOX, irinotecan) in mCRC patients, whose tumors remain RAS/BRAF WT. The study will also evaluate the activity and efficacy of cetuximab re-introduction in combination with irinotecan as third line therapy in the concept of re-challenge for those patients that will be treated in second line with chemotherapy plus anti-angiogenic drugs (FOLFOX plus bevacizumab), having a RAS or BRAF mutant disease at the time of progression after FOLFIRI plus cetuximab first line treatment. A novel characteristic of this program is that the therapeutic algorithm will be defined at each treatment decision (first line, second line and third line) in a prospective fashion in each patient by liquid biopsy assessment of RAS/BRAF status.
Detailed Description: Based on dynamic and longitudinal liquid biopsy assessment of RAS/BRAF status, that will be prospectively performed before each line of treatment, mCRC patients will be treated with cetuximab in combination with chemotherapy throughout three lines of therapy, as follows: FOLFIRI plus cetuximab (first line); FOLFOX plus cetuximab (second line); irinotecan plus cetuximab (third line) in case of RAS/BRAF WT at each time point of progression. If at progression after the first line, the liquid biopsy assessment indicates RAS and or BRAF mutant status, patients will be treated with FOLFOX plus bevacizumab as the second line of therapy. If at progression after the second line, the liquid biopsy assessment indicates RAS and or BRAF mutant status, patients will be treated with regorafenib or trifluridine-tipiracil (investigator's choice), as third line of therapy. Each treatment will be administered using standard doses and schedules until progression of disease or unacceptable toxicity. This study will also evaluate the activity and efficacy of cetuximab re-introduction in combination with irinotecan as third line therapy in the concept of re-challenge for those patients that will be treated in second line with FOLFOX plus bevacizumab, having a RAS or BRAF mutant disease at the time of progression after FOLFIRI plus cetuximab first line treatment. A novel characteristic of this program is that the therapeutic algorithm will be defined at each treatment decision (first line, second line and third line) in a prospective fashion in each patient by liquid biopsy assessment of RAS/BRAF status
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
A.O.U. Ospedali Riuniti, Ancona, AN, Italy
Ente Ecclesiastico Ospedale Generale Regionale 'F. Miulli', Acquaviva Delle Fonti, BA, Italy
IRCCS Istituto Tumori 'Giovanni Paolo II', Bari, BA, Italy
Ospedale IRCCS 'Saverio de Bellis', Castellana Grotte, BA, Italy
Ospedale Sacro Cuore di Gesù - FATEBENEFRATELLI, Benevento, BN, Italy
P.O. Antonio Perrino, Brindisi, BR, Italy
A.O.U. Cagliari - Presidio Policlinico D. Casula, Monserrato, CA, Italy
A.R.N.A.S. Garibaldi - P.O. Garibaldi-Nesima, Catania, CT, Italy
A.O.U. Mater Domini, Catanzaro, CZ, Italy
Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, FG, Italy
P.O. 'Vito Fazzi', Lecce, LE, Italy
A.O. 'Pia Fondazione Cardinale G. Panico', Tricase, LE, Italy
Istituto Europeo di Oncologia, Milano, MI, Italy
A.O.U. Policlinico 'P. Giaccone', Palermo, PA, Italy
Istituto Oncologico Veneto IRCCS, Padova, PD, Italy
A.O.U. Pisana, Pisa, PI, Italy
A.O. San Carlo, Potenza, PZ, Italy
A.U.S.L. - IRCCS di Reggio Emilia - P.O. Arcispedale S.Maria Nuova, Reggio Emilia, RE, Italy
A.S.P. Ragusa - Ospedale Maria Paternò Arezzo, Ragusa, RG, Italy
A.O. San Camillo-Forlanini, Roma, RM, Italy
Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS, Roma, RM, Italy
Ospedale San Giuseppe Moscati, Statte, TA, Italy
A.O. Ordine Mauriziano, Torino, TO, Italy
A.O.U. dell'Università degli studi della Campania "Luigi Vanvitelli", Napoli, , Italy
Istituto Nazionale Tumori 'Fondazione G. Pascale', Napoli, , Italy
Contact Details
Name: Fortunato Ciardiello
Affiliation: A.O.U. dell'Università degli studi della Campania "Luigi Vanvitelli"
Role: PRINCIPAL_INVESTIGATOR
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