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Spots Global Cancer Trial Database for Folfiri/aflIbercept in Metastatic coloreCTal Cancer patIents With RAS Validated Wild typE Status

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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