Dr. Shirasu on the Design for the GALAXY Trial Examining ctDNA in CRC

Hiromichi Shirasu, MD, of the Shizuoka Cancer Center in Shizuoka, Japan, discusses the design of the GALAXY trial (UMIN000039205), part of the CIRCULATE-Japan project, which is examining circulating tumor DNA (ctDNA) in patients with resectable colorectal cancer (CRC).

GALAXY is a prospectively-conducted, large-scale, registry designed to monitor ctDNA status in patients with stage II to stage IV CRC who are undergoing surgical resection, according to Shirasu. Blood samples will be collected from patients before they undergo surgery, as well as at 4, 12, 24, 36, 48, 72, and 96 weeks after resection, Shirasu says. Additionally, computed tomography scans will be conducted every 6 months after surgery for 7 years, Shirasu adds.

Once results from the assay are received, patients can then be considered for enrollment to the phase 3 VEGA trial, which will assess observation vs adjuvant capecitabine plus oxaliplatin in patients from the GALAXY study who have high-risk stage II disease or low-risk stage III disease; or the phase 3 ALTAIR trial (NCT02305238), which will evaluate the superiority of trifluridine/tipiracil vs placebo in GALAXY participants with ctDNA status that remains positive after the standard therapy, Shirasu explains. Additional samples will also be collected for assessment, and a total of 2500 patients will be enrolled to the study, Shirasu concludes.