In the observational arm of the CIRCULATE-Japan study, among patients with stage II-IV ColorectalCancer, those with the presence of circulating tumorDNA post-tumor resection have a high recurrence risk & are likely to benefit from adjuvant chemotherapy
. However, as the bias of patient characteristics is inevitable in observational studies, we are conducting a randomized, phase III VEGA trial to assess the noninferiority of observation alone compared with standard ACT in patients with high-risk stage II or low-risk pathological stage III CRC who are confirmed to be ctDNA negative 4 weeks after surgery.
Potential limitations of these results include the observational nature of the study and the bias in patient characteristics. To partly mitigate these potential biases, we performed a multivariate analysis, demonstrating the clear benefit of ACT for reduction of recurrence risk in ctDNA-positive patients 4 weeks after surgery. Another limitation of the study is the nonfeasibility of conducting a randomized trial of ACT versus the observation arm in postsurgical ctDNA-positive patients in Japan.
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