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OPERA: OXALIPLATIN AND CETUXIMAB IN FIRST-LINE TREATMENT OF mCRCOpen, non-controlled, multicenter phase II study evaluating 5-FU/FA plus oxaliplatin (FOLFOX-4) plus cetuximab as first-line treatment for patients with undetectable EGFR-status in metastatic colorectal cancer.

ABSTRACT: Primary objectives: To assess the rate of best confirmed response of 5-FU/FA plus oxaliplatin plus cetuximab as first-line treatment for undetectable epidermal growth factor in metastatic colorectal cancer. Primary endpoints: The primary target variable related to efficacy is the best overall confirmed tumor response to therapy of either CR or PR . Secondary target variables related to efficacy comprise variables based on tumor response and survival time. The following variables describe those, which are directly related to tumor response: • The duration of response to assess the time from first assessment of CR or PR until the first date of PD or death• Disease control on therapy, i.e. best overall response is either CR, PR, SD, provided the confirmation criteria are met (see section 7.2.3) • Progression-free survival time of a patient being defined as the time in months from start of treatment until PD is observed or death occurs due to any cause within 90 days after the last tumor assessment. In addition, survival time and curative metastatic surgery will be of further interest.

DISEASE(S): Metastasized Colorectal Cancer,Colorectal Cancer Metastatic

PROVIDER: 2518616 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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