BO17920 - Kolonkarzinom

Bevacizumab in Kombination mit Capecitabine plus Oxaliplatin (XELOX) oder Fluorouracil/Leukovorin mit Oxaliplatin (FOLFOX-4) versus FOLFOX-4 Regime als alleinige adjuvante Chemotherapie beim Kolonkarzinom

Rekrutierung

Es werden aktuell Patienten in die Studie eingeschlossen.

Studiendesign

Randomisierte, multizentrische, 3-armige Phase III-Studie.

Studienziel

Primary outcome: Disease-free survival. Key secondary outcomes: Efficacy: Overall survival. Safety: Adverse events and laboratory abnormalities.

Synopsis

This study will evaluate the efficacy and safety of Avastin added to various combination regimens as adjuvant chemotherapy in chemotherapy-naive patients with colon cancer, who have had surgery. The anticipated time of study treatment is 6-12 months, and the target sample size is 500+ individuals.

Einschlusskriterien

adult patients
≥18 years of age
documented colon carcinoma
not a candidate for (neo) adjuvant radiotherapy
curative surgery not less than 4 and not more than 8 weeks prior to study randomization

Ausschlusskriterien

major surgical procedures, open biopsy, or significant traumatic injury, within 28 days prior to study treatment start
current or recent treatment (within 28 days prior to randomization) with another investigational drug, or participation in another investigational study
evidence of metastatic disease
previous anti-angiogenic treatment for any malignancy
previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for colon cancer
pregnant or lactating women
fertile men, or women of childbearing potential, not using adequate contraception