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This study investigates the link between the skin rash (skin toxicity) from Cetuximab treatment and tumor response in patients with metastatic colorectal cancer. It included patients over 18 with KRAS wild-type (normal) tumors receiving Cetuximab with first-line chemotherapy. It was a Phase 2 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Patients older than 18 years * Patient with histologically proven metastatic colorectal cancer with KRAS wild-type * Treatment with cetuximab in first line chemotherapy combined with FOLFOX or FOLFIRI * Patient has signed informed consent * Patient affiliated to the Social Security * Prescription of cetuximab in agreement with the Summary of Product Characteristics Exclusion Criteria: * Patients aged under 18 * Patients taking immunosuppressive therapy * Patient having a severe skin disease * No measurable metastasis * Patients with a contra-indication of cetuximab: hypersensitivity to cetuximab or to any excipients * Severe alteration of respiratory or cardiac function or severe coronary disease * Patients with contra-indication to chemotherapy FOLFOX and FOLFIRI * Participation in another research protocol * Patients not affiliated to the Social Security * Hospitalized patients without consent * Pregnant or nursing women, women of childbearing age with no effective contraception