{
  "abstract": "Tumor-informed circulating tumor DNA (ctDNA) enables detection of molecular residual disease (MRD) after curative resection of colorectal cancer (CRC), but whether early intervention improves outcomes remains uncertain. ALTAIR was a randomized, double-blind, phase 3 trial embedded in the CIRCULATE-Japan platform evaluating a post-adjuvant ctDNA surveillance strategy with treatment initiation upon molecular recurrence. Patients with resected stage 0–IV CRC who became ctDNA positive after completion of standard-of-care therapy and had no radiological evidence of disease were randomly assigned (1:1) to receive trifluridine/tipiracil (FTD/TPI) or placebo for 6 months. The primary endpoint was investigator-assessed disease-free survival (DFS). Between July 2020 and June 2023, 243 patients were randomized to FTD/TPI (n = 122) or placebo (n = 121). Median DFS was 9.30 months with FTD/TPI and 5.55 months with placebo (hazard ratio = 0.79, 95% confidence interval: 0.60–1.05, P = 0.107), and the primary endpoint was not met. FTD/TPI increased grade 3 or higher hematologic adverse events (73.0% versus 3.3%) without new safety signals. These findings indicate that post-adjuvant intervention with FTD/TPI did not significantly improve DFS in ctDNA-positive patients without radiological disease. ClinicalTrials.gov identifier: NCT04457297 . In the randomized, double-blind phase 3 ALTAIR trial, patients with resected colorectal cancer who became positive for circulating tumor DNA during post-adjuvant surveillance received trifluridine/tipiracil hydrochloride therapy, which did not significantly prolong disease-free survival compared with placebo.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Data Science, National Cancer Center Hospital East, Kashiwa, Japan",
    "Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan",
    "Translational Research Support Office, National Cancer Center Hospital East, Kashiwa, Japan",
    "Department of Colorectal Surgery, Kansai Medical University, Osaka, Japan",
    "Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan",
    "Department of Surgery, NHO Osaka National Hospital, Osaka, Japan",
    "Gastrointestinal Cancer Center, Sano Hospital, Kobe, Japan",
    "Department of Gastroenterological Surgery and Pediatric Surgery, Gifu University, Graduate School of Medicine. Center for One Medicine Innovative Translational Research (COMIT), Gifu University, Gifu, Japan",
    "Department of Advanced Medicine and Innovative Technology, Kyushu University Hospital, Fukuoka, Japan",
    "Department of Cancer Center, Hokkaido University Hospital, Sapporo, Japan",
    "Department of Gastroenterological Surgery, Kanagawa Cancer Center, Yokohama, Japan",
    "Department of Surgery 1, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan",
    "Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan",
    "Department of Medical Oncology, Tohoku University Hospital, Sendai, Japan",
    "Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan",
    "Department of Surgery, Gastro-Intestinal Center, Kyoto Katsura Hospital, Kyoto, Japan",
    "Department of Surgery Shimane Prefectural Central Hospital, Shimane, Japan",
    "Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan",
    "EPS Corporation, Tokyo, Japan",
    "Clinical Research Support Office, National Cancer Center Hospital East, Kashiwa, Japan",
    "Oncology, Natera, Inc., Austin, TX, USA",
    "Department of Surgery, Osaka International Medical & Science Center, Osaka, Japan",
    "Department of Oncology, University of Oxford, Oxford, UK",
    "Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA",
    "Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan",
    "Department of Data Science, National Cancer Center Hospital East, Kashiwa, Japan. tyoshino@east.ncc.go.jp",
    "Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan. tyoshino@east.ncc.go.jp",
    "Translational Research Support Office, National Cancer Center Hospital East, Kashiwa, Japan. tyoshino@east.ncc.go.jp"
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 34,
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      "name": "Hideaki Bando",
      "orcid": "0000-0001-5041-2765"
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      "name": "Jun Watanabe"
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      "orcid": "0000-0003-3948-5044"
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      "name": "Dai Manaka",
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      "name": "Akiyoshi Kanazawa",
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      ],
      "name": "Yi-Hsin Liang"
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      "name": "Kun‐Huei Yeh",
      "orcid": "0000-0002-7306-174X"
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      "name": "Yuko Watsuji"
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      "name": "Yuko Yamamoto"
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      "name": "Makoto Fukui",
      "orcid": "0000-0003-2911-6499"
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      "name": "Shruti Sharma",
      "orcid": "0000-0003-0290-1569"
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      "name": "Vasily N. Aushev",
      "orcid": "0000-0001-8003-358X"
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      "name": "Adham Adel Jurdi",
      "orcid": "0000-0002-2985-3053"
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      "name": "Matthew Rabinowitz",
      "orcid": "0009-0006-3109-4232"
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      "name": "MC Liu",
      "orcid": "0000-0002-8206-5232"
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      "name": "Alexey A. Aleshin",
      "orcid": "0000-0002-0425-0301"
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      "name": "Ichiro Takemasa",
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      "name": "Takayuki Yoshino",
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      "name": "Takeshi Kato"
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  "bibtex": "https://research.draconitic.com/paper/9xkz4r5ceex00.bib",
  "cited_by": 18,
  "doi": "10.1038/s41591-026-04428-0",
  "fulltext_url": null,
  "id": "9xkz4r5ceex00",
  "issns": [
    "1078-8956",
    "1546-170X",
    "1744-7933"
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  "landing_url": "https://doi.org/10.1038/s41591-026-04428-0",
  "language": "en",
  "licence": "CC-BY-NC-ND",
  "licence_label": "CC BY-NC-ND",
  "licence_source": "journal",
  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
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  "native_subjects": [
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      "2730|Colorectal Cancer Treatments and Studies"
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  "pdf_url": "https://www.nature.com/articles/s41591-026-04428-0.pdf",
  "pmcid": "PMC13375530",
  "pmid": "42260101",
  "published": "2026-06-08",
  "publisher": "Nature Portfolio",
  "ris": "https://research.draconitic.com/paper/9xkz4r5ceex00.ris",
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    {
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  "subjects": [
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      "field": "medicine",
      "origin": "openalex:2730|Colorectal Cancer Treatments and Studies",
      "subfield": "oncology"
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  "title": "Post-adjuvant chemotherapy in ctDNA-positive patients with resected colorectal cancer: a randomized phase 3 trial",
  "title_text": "Post-adjuvant chemotherapy in ctDNA-positive patients with resected colorectal cancer: a randomized phase 3 trial",
  "type": "peer-reviewed",
  "updated_at": "2026-11-09T13:21:15Z",
  "url": "https://research.draconitic.com/paper/9xkz4r5ceex00",
  "venue": "Nature Medicine",
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