OnCo
trialsTrialActive

CIRCULATE-Japan (GALAXY / VEGA / ALTAIR)

Japan's national programme tests whether a blood test after surgery should decide who gets chemotherapy, and whether treating a positive test early helps.

GALAXY (observational, >2,000 patients) showed ctDNA positivity 4 weeks post-surgery is the strongest predictor of recurrence (Nature Medicine 2023). ALTAIR (ctDNA-positive, randomised to trifluridine/tipiracil vs placebo) missed its DFS endpoint (2024), suggesting late-line chemotherapy does not clear MRD. VEGA (ctDNA-negative, omit vs give CAPOX) is ongoing. Together with DYNAMIC these define the state of ctDNA-guided adjuvant therapy in CRC.

Setting
Resected stage II-IV colorectal cancer: ctDNA (Signatera) to guide adjuvant chemotherapy de-escalation (VEGA) or escalation with trifluridine/tipiracil (ALTAIR)
Phase
Phase 3
Sponsor
National Cancer Center Japan
Headline result
GALAXY: ctDNA+ post-op HR for recurrence ~10; ALTAIR: DFS endpoint not met.
Reported
2023
Replication
DYNAMIC (Australia) independently supports de-escalation in ctDNA-negative stage II; escalation strategies remain unproven.

Connected

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