{"entity":{"id":"circulate-japan","kind":"trial","name":"CIRCULATE-Japan (GALAXY / VEGA / ALTAIR)","aka":["GALAXY","VEGA","ALTAIR"],"tldr":"Japan's national programme tests whether a blood test after surgery should decide who gets chemotherapy, and whether treating a positive test early helps.","summary":"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.","status":"active","asOf":"2026-09-07","links":[{"label":"GALAXY, Nature Medicine 2023","url":"https://www.nature.com/articles/s41591-022-02115-4"},{"label":"ALTAIR: post-adjuvant chemotherapy in ctDNA-positive patients with resected colorectal cancer (Nature Medicine 2026)","url":"https://doi.org/10.1038/s41591-026-04428-0"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["mrd-testing","liquid-biopsy"],"targets":[],"drugs":["signatera","trifluridine-tipiracil","capox"],"companies":[],"institutions":["ncc-japan"],"pathways":[],"terms":["mrd","ctdna"],"trials":["dynamic","altair","dynamic-iii"],"people":["jeanne-tie","yoshino-takayuki"],"bottlenecks":[],"keyPapers":["paper-henriksen-ctdna-stage-iii-colorectal-improve-it-ccr-2022","paper-nakamura-triumph-ctdna-pertuzumab-trastuzumab-her2-colorectal-nat-med-2021"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Resected stage II-IV colorectal cancer: ctDNA (Signatera) to guide adjuvant chemotherapy de-escalation (VEGA) or escalation with trifluridine/tipiracil (ALTAIR)","sponsor":"National Cancer Center Japan","result":"GALAXY: ctDNA+ post-op HR for recurrence ~10; ALTAIR: DFS endpoint not met.","yearReported":2023,"enrolledBasis":"registry","outcomes":[{"endpoint":"GALAXY (observational): recurrence risk by post-operative ctDNA status (4 weeks after surgery)","arms":[{"name":"ctDNA-positive","note":"n = 1,039 resectable stage II-IV CRC; ctDNA positivity was the strongest prognostic factor and identified who benefited from adjuvant chemotherapy (HR 6.59)"},{"name":"ctDNA-negative"}],"hr":10,"p":"<0.0001","source":"https://doi.org/10.1038/s41591-022-02115-4"},{"endpoint":"ALTAIR (randomised phase 3): disease-free survival in post-adjuvant ctDNA-positive patients","primary":true,"unit":"months","arms":[{"name":"Trifluridine/tipiracil","n":122,"value":9.3,"note":"Primary endpoint not met"},{"name":"Placebo","n":121,"value":5.55}],"hr":0.79,"ci":[0.6,1.05],"p":"0.107","source":"https://doi.org/10.1038/s41591-026-04428-0"}],"replication":"GALAXY's prognostic ctDNA signal matches DYNAMIC, CIRCULATE-PRODIGE and BESPOKE cohorts; the interventional ALTAIR arm shows that detecting molecular recurrence does not yet translate into a DFS gain with trifluridine/tipiracil. VEGA (de-escalation) still pending."},"route":"/trials/circulate-japan/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"technology":[{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"},{"id":"mrd-testing","kind":"technology","name":"MRD / molecular residual disease testing","route":"/technologies/mrd-testing/"}],"drug":[{"id":"capox","kind":"drug","name":"CAPOX (capecitabine, oxaliplatin)","route":"/drugs/capox/"},{"id":"signatera","kind":"drug","name":"Signatera","route":"/drugs/signatera/"},{"id":"trifluridine-tipiracil","kind":"drug","name":"Trifluridine/tipiracil","route":"/drugs/trifluridine-tipiracil/"}],"institution":[{"id":"ncc-japan","kind":"institution","name":"National Cancer Center Hospital","route":"/institutions/ncc-japan/"}],"term":[{"id":"ctdna","kind":"term","name":"Circulating tumour DNA (ctDNA)","route":"/terms/ctdna/"},{"id":"colectomy","kind":"term","name":"Colectomy","route":"/terms/colectomy/"},{"id":"de-escalation","kind":"term","name":"De-escalation, escalation and response-adapted therapy","route":"/terms/de-escalation/"},{"id":"mrd","kind":"term","name":"Minimal / molecular residual disease (MRD)","route":"/terms/mrd/"},{"id":"real-world-evidence","kind":"term","name":"Real-world evidence","route":"/terms/real-world-evidence/"},{"id":"registry-based-trial","kind":"term","name":"Registry-based randomised trial","route":"/terms/registry-based-trial/"},{"id":"trial-registration","kind":"term","name":"Trial registration and results reporting (ClinicalTrials.gov, EU CTR)","route":"/terms/trial-registration/"}],"trial":[{"id":"altair","kind":"trial","name":"ALTAIR","route":"/trials/altair/"},{"id":"circulate-us","kind":"trial","name":"CIRCULATE-US","route":"/trials/circulate-us/"},{"id":"dynamic","kind":"trial","name":"DYNAMIC","route":"/trials/dynamic/"},{"id":"dynamic-iii","kind":"trial","name":"DYNAMIC-III","route":"/trials/dynamic-iii/"},{"id":"tracc","kind":"trial","name":"TRACC","route":"/trials/tracc/"}],"person":[{"id":"jeanne-tie","kind":"person","name":"Jeanne Tie","route":"/people/jeanne-tie/"},{"id":"yoshino-takayuki","kind":"person","name":"Takayuki Yoshino","route":"/people/yoshino-takayuki/"}],"paper":[{"id":"paper-henriksen-ctdna-stage-iii-colorectal-improve-it-ccr-2022","kind":"paper","name":"Circulating tumor DNA in stage III colorectal cancer, beyond minimal residual disease detection, toward assessment of adjuvant therapy efficacy and clinical behavior of recurrences","route":"/key-papers/paper-henriksen-ctdna-stage-iii-colorectal-improve-it-ccr-2022/"},{"id":"paper-nakamura-triumph-ctdna-pertuzumab-trastuzumab-her2-colorectal-nat-med-2021","kind":"paper","name":"Circulating tumor DNA-guided treatment with pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer: a phase 2 trial (TRIUMPH)","route":"/key-papers/paper-nakamura-triumph-ctdna-pertuzumab-trastuzumab-her2-colorectal-nat-med-2021/"},{"id":"paper-galaxy-signatera-nat-med-2023","kind":"paper","name":"GALAXY: tumour DNA in blood four weeks after bowel cancer surgery predicts relapse tenfold","route":"/key-papers/paper-galaxy-signatera-nat-med-2023/"}],"idea":[{"id":"idea-bio2-national-mrd-platform","kind":"idea","name":"A national platform trial that every ctDNA-positive patient can join","route":"/ideas/idea-bio2-national-mrd-platform/"},{"id":"idea-ctdna-guided-adjuvant-crc","kind":"idea","name":"ctDNA-guided adjuvant therapy as the default in stage II-III colon cancer","route":"/ideas/idea-ctdna-guided-adjuvant-crc/"},{"id":"idea-tr2-ctdna-mrd-qualification","kind":"idea","name":"Formally qualify tumour-DNA blood tests as a surrogate endpoint for adjuvant trials","route":"/ideas/idea-tr2-ctdna-mrd-qualification/"},{"id":"idea-bio2-platelet-cloak-aspirin-mrd","kind":"idea","name":"Strip the platelet coat off travelling tumour cells in ctDNA-positive patients","route":"/ideas/idea-bio2-platelet-cloak-aspirin-mrd/"},{"id":"idea-crc-ctdna-de-escalation-beyond-stage-ii","kind":"idea","name":"Take ctDNA-guided de-escalation beyond stage II, and stop escalating on a positive result until a trial says it helps","route":"/ideas/idea-crc-ctdna-de-escalation-beyond-stage-ii/"}],"roadmap":[{"id":"colorectal-roadmap","kind":"roadmap","name":"Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation","route":"/roadmaps/colorectal-roadmap/"},{"id":"ctdna-tests","kind":"roadmap","name":"ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment","route":"/roadmaps/ctdna-tests/"},{"id":"diagnostics-roadmap","kind":"roadmap","name":"Diagnostics roadmap: stains → gene panels → blood tests that decide treatment","route":"/roadmaps/diagnostics-roadmap/"},{"id":"trial-modernisation-roadmap","kind":"roadmap","name":"Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on","route":"/roadmaps/trial-modernisation-roadmap/"}],"bottleneck":[{"id":"b-dormancy-mrd","kind":"bottleneck","name":"Dormant cells and minimal residual disease","route":"/bottlenecks/b-dormancy-mrd/"},{"id":"b-metastasis-biology","kind":"bottleneck","name":"Metastasis is understood least and studied last","route":"/bottlenecks/b-metastasis-biology/"},{"id":"b-tumor-heterogeneity","kind":"bottleneck","name":"Tumour heterogeneity and clonal evolution","route":"/bottlenecks/b-tumor-heterogeneity/"}]}}