The primary objective of this study is to evaluate the efficacy of Irinotecan in combination with FOLFOX+Bevacizumab versus FOLFOX+Bevacizumab alone in the first-line treatment of patients with metastatic colorectal cancer.
5-Fluorouracil and oxaliplatin (FOLFOX-Regimen) in combination with bevacizumab is regarded as standard first-line treatment in metastatic colorectal cancer \[Saltz et al., 2008\]. Current studies established the role of the FOLFOXIRI regimen \[Souglakos et al., 2006, Falcone et al., 2007\]. A further intensification of the therapy seems feasible yielding response rates up to 84% and a disease control rate up to 100% \[Falcone, 2008, Santomaggio, 2009, Masi, 2010\]. This trial evaluates the activity of an intensified first-line therapy for metastatic colorectal cancer compared to standard treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
bevacizumab at a dose of 5 mg/kg iv over 30 to 90 min (day 1) oxaliplatin at a dose of 85 mg/m2 iv over two hours (day 1) I-LV at a dose of 200 mg/m2 iv over two hours (day 1) 5-FU at a dose of 3200 mg/ m2 iv over 48 hours (day 1-3)
bevacizumab at a dose of 5 mg/kg iv over 30 to 90 min (day 1) irinotecan at a dose of 165 mg/m2 iv over two hours (day 1) oxaliplatin at a dose of 85 mg/m2 iv over two hours (day 1) I-LV at a dose of 200 mg/m2 iv over two hours (day 1) 5-FU at a dose of 3200 mg/ m2 iv over 48 hours (day 1-3)
progression free survival rate
Time frame: 9 months after first study drug administration
tumour response according to RECIST v 1.1
Time frame: until progression of disease for a maximum of two years after end of treatment
Secondary resection rate
Time frame: for a maximum of two years after end of treatment
Progression free survival rate
Time frame: until progression of disease for a maximum of two years after end of treatment
Overall survival
Time frame: until death for a maximum of two years after end of treatment
Adverse events
Toxicity of study medication
Time frame: 18 months after the date of last study drug administration
Quality of Life evaluated by questionnaire
Quality of Life evaluated using questionnaire EORTC QLQ-30
Time frame: Until end of treatment (maximum 2 years after first study drug administration)
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Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie
Berlin, Germany
Knappschaftskrankenhaus Bottrop
Bottrop, Germany
Onkologische Praxis
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Gemeinschaftspraxis für Hämatologie und Onkologie
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Studiengesellschaft Kátay + Reiser GbR
Cologne, Germany
Städtisches Klinikum Dessau
Dessau, Germany
Evangelisches Krankenhhaus Dinslaken
Dinslaken, Germany
Gemeinschaftspraxis Hämatologie-Onkologie
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Onkozenrum Dresden
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Onkologie Duisburg
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...and 41 more locations