Aflibercept or Bevacizumab as Second-line Treatment of RAS Mutated Metastatic Colorectal Cancer

  • STATUS
    Recruiting
  • End date
    May 11, 2024
  • participants needed
    220
  • sponsor
    National Cancer Institute, Naples
Updated on 24 January 2021
vegf
growth factor
oxaliplatin
fluoropyrimidine
EGFR
bevacizumab
vascular endothelial growth factor
aflibercept
folfiri regimen

Summary

Colorectal cancer is the third most frequent neoplasm after prostate and lung in man and breast and lung cancers in woman from Western Countries. The intensive study of predictive factors has strongly ameliorated the therapeutic flow-chart of metastatic colorectal cancer (mCRC) by allowing the selection of patients who benefit from specific therapies. In this context, the assessment of RAS (N- and K-) oncogene mutations is able to predict the response to anti-EGFR agents being mutated RAS mCRC patients resistant to these drugs. In this group of patients the use of anti-angiogenic drugs (bevacizumab and aflibercept) is predominant. Still to date there are no studies to guide oncologists in the selection of the best anti-angiogenic drug (bevacizumab beyond progression vs aflibercept) after failure of the first-line chemotherapy in RAS-M mCRC patients. The present is the first observational, pragmatic, prospective study aimed to report outcomes of mCRC patients treated with folfiri plus bevacizumab versus folfiri plus aflibercept in second-line treatment of mRAS mCRC. Furthermore, the serum levels of angiopoietin-1 (Ang-1), angiopoietin-2 (Ang-2), vascular endothelial growth factor-A and C (VEGF-A and C), stromal cell-derived factor-1 (SDF-1), platelet-derived growth factor beta (PDGF-), basic fibroblast growth factor (bFGF), interleukin-8 (IL-8), chemokine (C-C motif) ligand 2 (CCL2), and chemokine (C-C motif) ligand 5 (CCL5) and Placental Growth Factor (PlGF), will be evaluated before starting second-line chemotherapy with bevacizumab or aflibercept in order to evidence any pattern related to response and/or prognosis. The hypothesis is that knowledge of eventual unbalance of these factors could help to select the best anti-angiogenic drug in second-line treatment of mRAS mCRC patients.

Details
Condition Metastatic Colorectal Cancer
Treatment Folfiri/Bevacizumab, Folfiri/Aflibercept
Clinical Study IdentifierNCT04397601
SponsorNational Cancer Institute, Naples
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Cytological or histological diagnosis of RAS mutated mCRC
progression at first-line chemotherapy with fluoropyrimidines, oxaliplatin and bevacizumab
stage IV
age <75 years
ECOG Performance Status 0 or 1
life expectancy> 3 months
negative pregnancy test for all potentially childbearing women

Exclusion Criteria

presence of primary non-treated stenosing colorectal neoplasm
active or uncontrolled infections or bleedings
other concomitant uncontrolled diseases or blood laboratory values contraindicating the study drugs at clinician evaluation
presence of brain metastases
refusal or inability to provide informed consent
impossibility to guarantee follow-up
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