Optimal Maintenance Therapy With Bevacizumab After Induction in Metastatic Colorectal Cancer (CRC)

Summary

Investigating the efficacy of maintenance and reinduction treatment or no treatment and watchful waiting in subjects with inoperable or irresectable and non-progressive metastatic colorectal cancer after first line induction treatment for 24 weeks with a fluoropyrimidine-, oxaliplatin- and bevacizumab-based chemotherapy. The maintenance treatment with capecitabine or 5-FU/folinic acid and bevacizumab will be compared with a maintenance treatment with bevacizumab alone or no maintenance treatment. Reinduction treatment will be done in case of progression.

Timeline

Start

2009-08

Primary completion

2014-12

Completion

2015-08

Publications

• Lueong SS, Herbst A, Liffers ST, Bielefeld N, Horn PA, Tannapfel A, Reinacher-Schick A, Hinke A, Hegewisch-Becker S, Kolligs FT, Siveke JT. Serial Circulating Tumor DNA Mutational Status in Patients with KRAS-Mutant Metastatic Colorectal Cancer from the Phase 3 AIO KRK0207 Trial. Clin Chem. 2020 Dec 1;66(12):1510-1520. doi: 10.1093/clinchem/hvaa223.
• Hegewisch-Becker S, Nopel-Dunnebacke S, Hinke A, Graeven U, Reinacher-Schick A, Hertel J, Lerchenmuller CA, Killing B, Depenbusch R, Al-Batran SE, Lange T, Dietrich G, Tannapfel A, Arnold D. Impact of primary tumour location and RAS/BRAF mutational status in metastatic colorectal cancer treated with first-line regimens containing oxaliplatin and bevacizumab: Prognostic factors from the AIO KRK0207 first-line and maintenance therapy trial. Eur J Cancer. 2018 Sep;101:105-113. doi: 10.1016/j.ejca.2018.06.015. Epub 2018 Jul 20.
• Quidde J, Hegewisch-Becker S, Graeven U, Lerchenmuller CA, Killing B, Depenbusch R, Steffens CC, Lange T, Dietrich G, Stoehlmacher J, Reinacher A, Tannapfel A, Trarbach T, Marschner N, Schmoll HJ, Hinke A, Al-Batran SE, Arnold D. Quality of life assessment in patients with metastatic colorectal cancer receiving maintenance therapy after first-line induction treatment: a preplanned analysis of the phase III AIO KRK 0207 trial. Ann Oncol. 2016 Dec;27(12):2203-2210. doi: 10.1093/annonc/mdw425. Epub 2016 Oct 17.
• Hegewisch-Becker S, Graeven U, Lerchenmuller CA, Killing B, Depenbusch R, Steffens CC, Al-Batran SE, Lange T, Dietrich G, Stoehlmacher J, Tannapfel A, Reinacher-Schick A, Quidde J, Trarbach T, Hinke A, Schmoll HJ, Arnold D. Maintenance strategies after first-line oxaliplatin plus fluoropyrimidine plus bevacizumab for patients with metastatic colorectal cancer (AIO 0207): a randomised, non-inferiority, open-label, phase 3 trial. Lancet Oncol. 2015 Oct;16(13):1355-69. doi: 10.1016/S1470-2045(15)00042-X. Epub 2015 Sep 8.

Drugs

Indications