# ALTAIR

Source: https://onco.cc/trials/altair/  
OnCo record `altair` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Treating the blood test result before the cancer shows up on a scan did not work. It delayed relapse by about four months and caused severe blood toxicity in three-quarters of patients.

## Summary

ALTAIR was the double-blind randomised phase 3 trial embedded in the CIRCULATE-Japan platform. Patients with resected colorectal cancer who became ctDNA-positive after completing standard-of-care therapy, with no radiological evidence of disease, were randomised 1:1 to trifluridine/tipiracil or placebo for six months. Between July 2020 and June 2023, 243 patients were randomised (122 to the drug, 121 to placebo). Median disease-free survival was 9.30 against 5.55 months (hazard ratio 0.79, 95% CI 0.60 to 1.05, p=0.107) and the primary endpoint was not met. Grade 3 or higher haematological adverse events occurred in 73.0 against 3.3 percent. The conclusion is that late-line chemotherapy started at molecular recurrence does not clear minimal residual disease, and that a better drug, not earlier timing, is what ctDNA-positive patients need.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-24
- Registry id: NCT04457297
- Phase: 3
- Setting: Resected stage 0 to IV colorectal cancer that became ctDNA-positive after standard treatment, with no disease visible on scans: six months of trifluridine/tipiracil against placebo
- Sponsor: National Cancer Center Hospital East
- Enrolled: 243
- Result: Median disease-free survival 9.30 against 5.55 months (hazard ratio 0.79, p=0.107): primary endpoint not met.
- Outcomes: Disease-free survival: Trifluridine/tipiracil 9.3 months vs Placebo 5.55 months, HR 0.79
- Replication: DYNAMIC-III reached the same conclusion for escalation in ctDNA-positive stage III disease.

## Sources

- ClinicalTrials.gov NCT04457297: https://clinicaltrials.gov/study/NCT04457297
- ALTAIR: post-adjuvant chemotherapy in ctDNA-positive patients with resected colorectal cancer (Nature Medicine 2026): https://doi.org/10.1038/s41591-026-04428-0
- CIRCULATE-Japan: ctDNA-guided adaptive platform trials (Cancer Science 2021): https://doi.org/10.1111/cas.14926

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- technologies: [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/), [MRD / molecular residual disease testing](https://onco.cc/technologies/mrd-testing/)
- drugs: [Signatera](https://onco.cc/drugs/signatera/), [Trifluridine/tipiracil](https://onco.cc/drugs/trifluridine-tipiracil/)
- institutions: [National Cancer Center Hospital](https://onco.cc/institutions/ncc-japan/)
- terms: [Circulating tumour DNA (ctDNA)](https://onco.cc/terms/ctdna/), [Colorectal cancer: the failed and stopped programmes, and why](https://onco.cc/terms/colorectal-failed-programmes/), [Minimal / molecular residual disease (MRD)](https://onco.cc/terms/mrd/)
- trials: [BESPOKE CRC](https://onco.cc/trials/bespoke-crc/), [CIRCULATE-Japan (GALAXY / VEGA / ALTAIR)](https://onco.cc/trials/circulate-japan/), [CIRCULATE-US](https://onco.cc/trials/circulate-us/), [DYNAMIC](https://onco.cc/trials/dynamic/), [DYNAMIC-III](https://onco.cc/trials/dynamic-iii/), [TRACC](https://onco.cc/trials/tracc/)

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