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To compare the efficacy in terms of progression free survival (PFS) of the addition of cetuximab to FOLFIRI versus FOLFIRI alone given as first line therapy in patients with advanced colorectal cancer (CRC). In particular, the predictive value of PTEN mutation will be assessed in determining the effect of cetuximab+FOLFIRI as compared to chemotherapy alone.
The study is an Italian, multicentre, open label, randomized trial on efficacy of first line therapies in patients with advanced CRC and KRAS wild-type, defined by molecular evaluation.
Patients will be randomized to receive:
- Cetuximab+FOLFIRI: cetuximab 500 mg/ m² starting dose, following everytwo- week doses of 500 mg/ m², given d1, followed after 1 hour by FOLFIRI: irinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2
- FOLFIRI alone, irinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2 until disease progression or unacceptable toxicity developed. Allocation to treatment will be centrally performed with 1:1 ratio using a biased-coin minimization procedure having centre, number of organs involved (1-2 vs. more than 2) and prior neo-adjuvant or adjuvant therapy (yes vs. no), as stratification variables. Access to random system will be allowed via web. Both efficacy and safety data will be collected. The investigators will assess response to treatment every 12 weeks based on imaging. Analysis of costs and quality of life will be performed. Following permanent treatment cessation, patients will be followed-up for survival. Patients with histologically documented metastatic wild- type CRC not suitable for curative-intent resection.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Ospedale Pesenti Fenaroli - Alzano L. - Alzano Lombardo
Active, not recruiting
Published on BioPortfolio: 2014-08-27T03:15:55-0400
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Tumor suppressor genes located in the 5q21 region on the long arm of human chromosome 5. The mutation of these genes is associated with the formation of colorectal cancer (MCC stands for mutated in colorectal cancer).
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