Folfiri/aflIbercept in Metastatic coloreCTal Cancer patIents With RAS Validated Wild typE Status — DISTINCTIVE  

Advanced Colorectal Cancer Clinical Trial

Official title: seconD-line Folfiri/aflIbercept in proSpecTIvely Stratified, Anti-EGFR resistaNt, Metastatic coloreCTal Cancer patIents With RAS Validated Wild typE Status

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Advanced Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT04252456
• Study type: Interventional
• Source: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
• Contact: Silvia Rota, DM
• Phone: +39 02 84968409
• Email: centrotrialgiscad@yahoo.it
• Status: Recruiting
• Phase: N/A
• Start date: April 23, 2018
• Completion date: February 2021