Journal of the Anus, Rectum and Colon
Online ISSN : 2432-3853
ISSN-L : 2432-3853
Trial Protocols
Monitoring ctDNA RAS Mutational Status in Metastatic Colorectal Cancer: A Trial Protocol of RAS-trace and RAS-trace-2 Studies
Kozo Kataoka, Takeshi Yamada, Manabu Shiozawa, Naoto Takase, Kazuma Ito, Kentaro Yamazaki, Jun Watanabe, Toshihiro Kudo, Takeshi Suto, Toshihiko Matsumoto, Kohei Murata, Yusuke Suwa, Shogen Boku, Hisateru Yasui, Nobuhisa Matsuhashi, Atsuyuki Maeda, Kiichi Sugimoto, Yusuke Matsumoto, Mitsuru Yokota, Johannes Fredebohm, Keita Mori, Masataka Ikeda
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Keywords: colorectal cancer, anti-EGFR monoclonal antibody, RAS-trace, RAS-trace-2, ctDNA
JOURNAL OPEN ACCESS

2024 Volume 8 Issue 2 Pages 132-136

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Abstract

Background: Spatial and temporal heterogeneities of RAS and other molecular genes should be considered in the treatment of metastatic colorectal cancer (mCRC) treated with anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs); acquired RAS mutation is sometimes observed at disease progression of treatment with the anti-EGFR mAb. At the same time, discrepancy of RAS status from tissues and circulating tumor DNA (ctDNA) in the same patient is sometimes observed. Based on this, we commenced two observational studies to clarify these heterogeneities of RAS and BRAF in mCRC, using next generation sequencing from liquid biopsy.

Methods/Design: RAS-trace study is an observational study to monitor ctDNA RAS/BRAF/PIK3CA status every 4-12 weeks using the Plasma-SeqSensei™ CRC RUO Kit (Sysmex Inostics GmbH) in mCRC with RAS/BRAF wild-type (wt) on tumor tissue. The primary endpoint was the time to the acquired RAS mutations. A total of 42 patients has been accrued. RAS-trace-2 study is also an observational study aimed at comparing the efficacy of the anti-EGFR mAb in ctDNA RAS/BRAF wt with ctDNA RAS or BRAF mutant mCRC patients, whose RAS/BRAF are wt in tumor tissue. The primary endpoint was progression-free survival in patients with ctDNA RAS/BRAF wt and RAS or BRAF mutant. A total of 240 patients will be accrued over 2 years.

Discussion: These trials will help us understanding the clinical significance of spatial and temporal heterogeneities of RAS, BRAF and other genes, while optimizing the anti-EGFR mAb treatment strategies in mCRC.

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© 2024 The Japan Society of Coloproctology

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