Optimal Anti-EGFR Treatment of mCRC Patients With Low-Frequency RAS Mutation

Treatment Related Cancer Clinical Trial

Official title: FIRE-5 -Study: Optimal Anti-EGFR Treatment of mCRC Patients With Low-Frequency RAS Mutation

Status Not yet recruiting

Clinical Trial Summary

The present hypothesis is that anti-EGFR agents are active in tumors with low-level RAS mutation when the majority of tumor cells is still sensitive. While response rate may be high and may reflect sensitivity to anti-EGFR agents, PFS is anticipated to be shorter than in RAS wild-type patients due to the faster development of resistance when sensitive cells are eradicated and when the RAS-mutant anti-EGFR resistant clones become predominant.

The characteristics of low-level RAS mutant tumors would be:

• Objective response rate (ORR) high (reflecting the sensitive clone)

• Progression-free survival (PFS) short (reflecting the more rapid outgrowth of RAS mutant clones)

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Neoplasms, Second Primary
• Treatment Related Cancer

• NCT number: NCT04034173
• Study type: Interventional
• Source: Ludwig-Maximilians - University of Munich
• Contact: Volker Heinemann, Prof. Dr.
• Phone: +49 89 4400
• Email: volker.heinemann@med.med.uni-muenchen.de
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 1, 2019
• Completion date: August 1, 2026