FFCD 2006 – NEORAF : A MULTI-CENTRE, OPEN-LABEL, PILOT TRIAL EVALUATING THE COMBINATION ENCORAFENIB AND CETUXIMAB IN A NEOADJUVANT SETTING IN PATIENTS WITH BRAF V600E-MUTATED LOCALISED COLON OR UPPER RECTUM CANCER

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514107-34-00

Acronym

FFCD 2006 NEORAF

Enrollment

Registered

2024-07-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BRAF V600E-MUTATED LOCALISED COLON OR UPPER RECTUM CANCER

Brief summary

To assess, in patients with localized BRAFV600E mutated CRC treated with neoadjuvant encorafenib and cetuximab: Safety and Feasibility

Detailed description

Non serious Toxicities (related and not related)., Overall survival, Disease free survival, The response rate in CT-scan according to RECIST 1.1 criteria, Post-operative morbidity and mortality, Quality of life (EQ5D), Tumour regression rate (TRG0 to TRG2), Recurrence free survival, The dose intensity of cetuximab and encorafenib

Interventions

DRUGErbitux 5 mg/mL solution for infusion

DRUGBraftovi 75 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To assess, in patients with localized BRAFV600E mutated CRC treated with neoadjuvant encorafenib and cetuximab: Safety and Feasibility	—

Secondary

Measure	Time frame
Non serious Toxicities (related and not related)., Overall survival, Disease free survival, The response rate in CT-scan according to RECIST 1.1 criteria, Post-operative morbidity and mortality, Quality of life (EQ5D), Tumour regression rate (TRG0 to TRG2), Recurrence free survival, The dose intensity of cetuximab and encorafenib	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026