CAPRI2 GOIM study - Investigate the efficacy and safety of a biomarker-driven cetuximab-based treatment regimen over 3 treatment lines in mCRC patients with RAS/BRAF wt tumors at start of first line.

Studio Clinico

Patologia: Tumori del colon retto

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Prima linea, Seconda linea, Terza/N linea

Criteri di inclusione: 

Patients eligible for inclusion in this study have to meet all of the following criteria at the start of first line treatment:
1. Histologically proven diagnosis of colorectal adenocarcinoma
2. Diagnosis of metastatic disease
3. RAS and BRAF wild-type status of FFPE analysis of primary colorectal cancer and/or related metastasis
4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST criteria, vers.1.1)
5. Male or female patients ≥ 18 years of age
6. ECOG Performance Status 0,1
7. Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment as defined by the following parameters:
Bone marrow:
    – Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
    – Hemoglobin (Hgb) ≥ 9 g/dL
    – Platelets ≥ 100 x 109/L
Liver function:
    – Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and ALT (SGPT) ≤ 2.5 x ULN, except in patients with tumor involvement of the liver who must have AST and ALT ≤ 5 xnnULN
Renal function:
    – Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 mL/min
8. 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
9. If female and of childbearing potential, or if male, agreement to use adequate contraception (e.g., abstinence, intrauterine device, oral contraceptive, or double-barrier method), during the study and until at least 3 months after last dose of study treatment administration, based on the judgment of the Investigator or a designated associate
10. Signed informed consent obtained before screening.

Criteri di esclusione: 

-

Numero di pazienti previsti: 

200

Trattamento sperimentale: 

FOLFIRI + cetuximab (1st line)
FOLFOX + cetuximabab (2nd line)
FOLFOX + bevacizumab (2nd line)
Regorafenib 160 mg day 1-21 every 28 days (3rd line)
Trifluridine-tipiracil, 35 mg/m2 twice daily on Days 1 to 5 and Days 8 to 12 on a cycle of 28 days (3rd line)
Irinotecan plus cetuximab (3rd linee)

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

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.

Obiettivi secondari dello studio: 

To assess the efficacy of a biomarker-driven cetuximab-based treatment regimen over 3 treatment lines in patients with RAS/BRAF WT mCRC at start of first line, based on additional measures according to secondary endpoints:
– Progression free survival (PFS) for each line
– Overall survival (OS)
– Safety profile
– Quality of life (QoL)
Molecular profiles of tumor tissue and liquid biopsy samples (somatic mutations identified in tumor tissue by next generation sequencing) and surrogate markers of treatment activity (changes in molecular profile of liquid biopsies). Analysis of the composition of gut microbiome and the influence on treatment outcome and tolerability.

Periodo previsto di arruolamento: 26 mesi

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2020-003008-15

Data di inserimento: 28.03.2022

Promotore

GOIM (Gruppo Oncologico dell'Italia Meridionale)

CRO

CLINICAL RESEARCH TECHNOLOGY

Principal Investigator ITALIA

Università degli Studi della Campania L. Vanvitelli, Napoli

Riferimento: Prof. Fortunato Ciardiello

Telefono: 0815666760

Email: fortunato.ciardiello@unicampania.it

Localita: Napoli