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The purpose of this study is to assess the efficacy of FOLFOX + panitumumab followed by FOLFIRI + bevacizumab (Sequence 1) versus FOLFOX + bevacizumab followed by FOLFIRI + panitumumab (Sequence 2) in untreated patients with wild-type RAS metastatic, primary left-sided, unresectable colorectal cancer
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Inclusion criteria
Man or woman at least 18 years old.
Capable of understand, sign and date an informed consent approved by an IEC.
Histologically confirmed adenocarcinoma of the left colon or rectum (originate in the splenic flexure, descending colon, sigmoid colon, or rectum) in patients with unresectable (not amenable to radical surgery of metastases at the study inclusion) metastatic (M1) disease.
Patients who had wild-type RAS status confirmed as per standard of care according to international guidelines prior to first-line initiation.
*RAS analysis should include at least KRAS exons 2, 3 and 4 (codons 12, 13, 59, 61, 117 and 146) and NRAS exons 2, 3 and 4 (codons 12, 13, 59, 61 and 117)
At least one unidimensionally measurable lesion per RECIST criteria (version 1.1).
ECOG performance status < 2.
Adequate bone marrow function: neutrophils ≥1.5 x109 / L; platelets ≥100 x109 /L; haemoglobin ≥ 9 g/dL.
Hepatic, renal and metabolic function as follows:
Exclusion criteria
Primary purpose
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419 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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