A randomized, phase III trial of capecitabine plus bevacizumab (Cape-Bev) versus capecitabine plus irinotecan plus bevacizumab (CAPIRI-Bev) in first-line treatment of metastatic colorectal cancer: The AIO KRK 0110 Trial/ML22011 Trial
2011

Comparing Two Treatments for Metastatic Colorectal Cancer

Sample size: 516 publication Evidence: moderate

Author Information

Author(s): Clemens Giessen, Ludwig Fischer, Axel Hinke, Sebastian Stintzing, Frank Kullmann, Ursula Vehling-Kaiser, Julia Mayerle, Markus Bangerter, Claudio Denzlinger, Markus Sieber, Christian Teschendorf, Jens Freiberg-Richter, Christoph Schulz, Dominik Paul Modest, Nicolas Moosmann, Philipp Aubele, Volker Heinemann

Primary Institution: Department of Medical Oncology, Klinikum Grosshadern, University of Munich, Germany

Hypothesis

Does the combination of capecitabine plus bevacizumab provide better outcomes than capecitabine plus irinotecan plus bevacizumab in first-line treatment of metastatic colorectal cancer?

Conclusion

The trial aims to determine if a less intensive treatment strategy can effectively manage metastatic colorectal cancer while minimizing toxicity.

Supporting Evidence

  • Combination chemotherapy does not significantly improve overall survival compared to sequential use of cytotoxic agents.
  • Previous studies have shown that the combination of capecitabine and bevacizumab is effective in treating metastatic colorectal cancer.
  • The trial aims to provide insights into treatment strategies for asymptomatic patients with metastatic colorectal cancer.

Takeaway

This study is testing two ways to treat a type of cancer that has spread, to see which one works better and is safer.

Methodology

This is a two-arm, multicenter, open-label randomized phase III trial comparing the efficacy and safety of two treatment regimens in patients with unresectable metastatic colorectal cancer.

Potential Biases

Potential bias due to the open-label design and the specific inclusion criteria.

Limitations

The study may not be applicable to elderly or frail patients and excludes those with symptomatic tumor disease.

Participant Demographics

Patients with unresectable metastatic colorectal cancer, ECOG performance status 0-1, aged 18 years and older.

Statistical Information

Statistical Significance

p ≤ 0.05

Digital Object Identifier (DOI)

10.1186/1471-2407-11-367

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