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

Die Studie rekrutiert aktuell Patienten.

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

Studienassistentin

Frau Neufang, Telefon: 06131 17-6863

Studienleiter

Herr PD Dr. Stephan Kanzler
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