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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:
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Inclusion criteria
Histologically confirmed, UICC stage IV metastatic adenocarcinoma of the colon or rectum
Primarily non-resectable metastases or surgical resection refused by the patient
RAS mutation determined by the local pathology
Age ≥18
ECOG performance status 0-2
Patients suitable for chemotherapy administration
Patient's written declaration of consent obtained
Estimated life expectancy > 3 months
Presence of at least one measurable reference lesion according to the RECIST 1.1 criteria
Primary tumor tissue available and patient consents to storage and molecular and genetic profiling of tumor material. Molecular profiling of blood samples is optionally performed.
Adequate bone marrow function:
Adequate hepatic function:
Adequate renal function:
▫ Creatinine clearance (calculated according to Cockcroft and Gault) ≥ 50 mL/min
No previous chemotherapy for metastatic disease. Patient with need of immediate treatment (high tumor load, symptoms) may have received one application of FOLFIRI prior to study treatment.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
120 participants in 3 patient groups
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Central trial contact
Sebastian Stintzing, Prof. Dr.; Volker Heinemann, Prof. Dr.
Data sourced from clinicaltrials.gov
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