Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer
Metastatic Colorectal Cancer
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring metastatic colorectal cancer, FOLFOX 6, FOLFIRI
Eligibility Criteria
Inclusion Criteria: Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum Metastatic colorectal carcinoma not suitable for curative-intent resection Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment Presence of at least one lesion measurable unidimensional by CT scan or MRI (Target lesion(s) must not lie within an irradiated area) ECOG performance status of < 2 at study entry Exclusion Criteria: Brain metastasis (known or suspected) Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or irinotecan. Adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy treatment free interval is > 6 months Surgery (excluding diagnostic biopsy) or irritation within 4 weeks prior to study entry Cocurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol Any investigational agent(s) within 4 weeks prior to entry Previous exposure to EGFR-pathway targeting therapy
Sites / Locations
- LKH Leoben, Abt. für Innere Medizin
- Univ. Klinik für Innere Medizin I
- Institute of Oncology
- University Hospital "Queen Joanna"
- SBALO National Oncology Center
- University Hospital for Tumors
- University Hospital Rebro
- Bank of Cyprus Oncology Center
- Univ. Hospital Brno, Dept. Of Clinical Oncology
- Charles University Prague, Dep. of Oncology
- National Medical Center
- Markusovsy Hospital
- Csolnoky Ferenc County Hospital
- Hadassah Medical Center
- Souraski Medical Center
- Hospital Amadora Sintra, Servico de Oncologia
- Hospital de Beja
- Hospital Distrital de Faro
- Hospital Geral de Sto. António
- Hospital San Teotóno -
- Institutul Oncologic Bucuresti
- Institutul Oncologic Cluj
- National Cancer Institute
- Institute of Oncology
- Ankara Hacettepe University, Oncology Unit
- Gazi University Medical Faculty
- 9 Eyul University Medical Faculty, Dep of Oncology
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
FOLFOX 6
FOLFIRI
FOLFOX 6: Oxaliplatin 100 mg/m² d1 concurrent with Leucovorin 400 mg/m², followed by Bolus 5FU 400 mg/m² , followed by Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:
FOLFIRI: Irinotecan 180 mg/m² day 1 concurrent with Leucovorin 400 mg/m² followed by Bolus 5FU 400 mg/m², followed by Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks