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Brief Title: Folfiri/aflIbercept in Metastatic coloreCTal Cancer patIents With RAS Validated Wild typE Status
Official Title: seconD-line Folfiri/aflIbercept in proSpecTIvely Stratified, Anti-EGFR resistaNt, Metastatic coloreCTal Cancer patIents With RAS Validated Wild typE Status
Study ID: NCT04252456
Brief Summary: The study will a be a biologically enriched, prospectively stratified phase II trial in RAS wild type metastatic colorectal cancer patients progressing after first-line treatment with oxaliplatin, fluoropyrimidines and an anti-EGFR monoclonal antibody. All patients will receive aflibercept in combination with FOLFIRI according to the Italian label.
Detailed Description: The study will a be a biologically enriched, prospectively stratified phase II trial in RAS wild type metastatic colorectal cancer patients progressing after first-line treatment with oxaliplatin, fluoropyrimidines and an anti-EGFR monoclonal antibody. Eligible patients will be prospectively allocated to either of two groups according to VEGFR2 levels (ELISA-based technique, pg/ml) at study entry. Others angiogenetic factors levels concentration before and during treatment. VEGF, PlGF, HGF, VEGFR1, IL8, IL1a, T-cad, VEGFR3, SAP, VDBP, neuropilin1, CRP, endoglin plasma concentrations will be evaluated before each cycle according to an ELISA-based technique All patients will undergo a blood test for retrieving circulating tumor DNA (Liquid Biopsy) at selected time-points before and during treatment for determining whether the status of selected tumor biomarkers evolve during tumor progression by comparing different ctDNA samples. All patients will receive aflibercept in combination with FOLFIRI according to the Italian label.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
A.O. Treviglio-Caravaggio, P.le Ospedale n1, Treviglio, Bergamo, Italy
A.O. Humanitas Gavazzeni, Bergamo, BG, Italy
Policlinico Universitario D.Casula, Monserrato, Cagliari, Italy
A.O. Polo Oncologico Vito Fazzi, Lecce, LE, Italy
ASST-Rhodense, Rho, Milano, Italy
Istituto Clinico Humanitas, Rozzano, MI, Italy
AUSL di Piacenza, Piacenza, PC, Italy
Centro Riferimento, Aviano, PN, Italy
Azienda Ospedaliera San Carlo, Potenza, PZ, Italy
Ospedale Papa Giovanni XXIII, Bergamo, , Italy
Fondazione Poliambulanza, Via Bissolati 57, Brescia, , Italy
IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano, , Italy
IRCCS Istituto Europeo di Oncologia, Milano, , Italy
A.O.U. Policlinico di Modena, Modena, , Italy
A.O. S.Giovanni Calabita Fatebenefratelli, Roma, , Italy
Ospedale San Bortolo, Vicenza, , Italy