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A multicentre randomised phase II study of aflibercept plus chemotherapy in patients with colorectal liver-only metastases deemed to be inoperable or unsuitable for upfront liver resection

ABSTRACT: MAIN STUDY: Primary objectives:• Progression free survival (PFS) of FOLFIRI plus cetuximab versus FOLFIRI plus aflibercept in patients with liver metastases deemed to be inoperable or unsuitable for upfront resection and with with RAS wild type (WT) disease.• In patients with RAS mutant CRC, to compare progression free survival of FOLFOXIRI versus FOLFIRI plus aflibercept or FOLFOXIRI plus aflibercept in patients with liver metastases deemed to be inoperable or unsuitable for upfront resection. The primary Endpoint of the study is one year-PFS The genetic material (DNA) in cancer cells can influence whether cancer responds to anti-cancer treatments. One of those characteristics is determined by examining a gene called RAS. RAS is an important downstream protein in the epridermal growth factor receptor (EGFR) pathway. Previous research has shown that testing for RAS can help guide treatment for mCRC. If no mutations are identified in the RAS genes, the tumour is referred Primary endpoints: FOR MAIN STUDY: To measure 1-year progression free survival (PFS) in patients treated on the study. This will be measured from date of randomisation to date of first appearance of disease progression, relapse, death from any cause; patients alive without progression or relapse will be censored at date last known to be alive. FOR SAFETY RUN-IN PHASE: In patients with metastatic colorectal cancer (CRC), to find the maximum tolerated dose (MTD)of FOLFOXIRI plus aflibercept

DISEASE(S): Colorectal Cancer,Colorectal Cancer With Liver Metastases

PROVIDER: 2533044 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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