This pilot study is being mounted to assess whether treatment assignment by ERCC-1 gene expression status suggests better clinical results from historical experience in metastatic colorectal cancer (mCRC). In wild type KRAS mCRC patients treated with either FOLFOX or FOLFIRI in combination with cetuximab the median response rate is approximately 60-65%. Biomarker directed treatment in this study may demonstrate that patients with low ERCC-1 treated with FOLFOX and cetuximab, and those with high ERCC-1 treated with FOLFIRI and cetuximab, will improve response rate to 70-75%. KRAS wild type patients will be treated with 6 cycles of one of the following regimens chosen for optimization based on patient characteristics (primary treatment phase). Patients with ERCC-1 \< 1.7 relative gene expression of ERCC-1 over ß-actin (ERCC-1 low) will be assigned to treatment with mFOLFOX6 in combination with Cetuximab. Patients with ERCC-1 gene expression \> 1.7 relative gene expression of ERCC-1 over over ß-actin (ERCC-1 high) will be assigned to treatment with FOLFIRI in combination with Cetuximab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie
Kufstein, Tyrol, Austria
KUK Linz - Med Campus III.: Univ.-Klinik für Hämatologie und Internistische Onkologie
Linz, Upper Austria, Austria
LKH Feldkirch, Interne E
Feldkirch, Vorarlberg, Austria
LKH Bludenz Innere Medizin
Bludenz, Austria
LKH Bregenz
Bregenz, Austria
KH Dornbirn, Innere Medizin
Dornbirn, Austria
Universitätsklinikum Graz
Graz, Austria
LKH Hohenems, Interne Intensivmedizin
Hohenems, Austria
Krankenhaus d. Barmherzigen Schwestern Linz
Linz, Austria
Universitätsklinik für Innere Medizin III mit Hämatologie, internistischer Onkologie, Infektologie, Rheumatologie und Onkologisches Zentrum
Salzburg, Austria
...and 1 more locations
Response
Treatment response according to Response Evaluation Criteria In Solid Tumors \[RECIST\]
Time frame: 5 years
Progression free survival (PFS)
Time frame: 5 years
Response rate
Description of group differences between ERCC-1 low and ERCC-1 high patients with respect to response rate, PFS and OS
Time frame: 5 years
Patient characteristics
Description of group differences between ERCC-1 low and ERCC-1 high patients with respect to KRAS status
Time frame: 5 years
Secondary resection rate
Time frame: 5 years
Molecular markers for toxicity
Time frame: 5 years
Number of adverse events during study treatment
Time frame: 5 years
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