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Colorectal NeoplasmsPhase 3ALTAIRNCT04457297

Initial Attack on Latent Metastasis Using TAS-102 for ct DNA Identified Colorectal Cancer Patients After Curative Resection

A Phase 3 study testing trifluridine and tipiracil in people with Colorectal Neoplasms and Trifluridine and Tipiracil, run by National Cancer Center Hospital East at 39 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial is a randomized, double-blind, multinational Phase III study to evaluate the efficacy and safety of preemptive treatment with FTD/TPI compared with administration of placebo as follow-up, which is the standard of care, in patients who underwent curative resection of colorectal cancer and then tested… Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
trifluridine and tipiracil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
243 participants
Where
39 sitesin 2 countries
Study dates
8 Jul 2020to 18 Jul 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who have been histopathologically diagnosed with colorectal adenocarcinoma
  • Patients who have undergone radical curative resection of the primary and metastatic tumors
  • Patients with colon or rectal cancer of Stage III based on final findings (T any N1/2 M0) (UICC TNM Classification, 8th Edition) who have a past history of standard postoperative chemotherapy
  • Patients who tested positive for ctDNA using SignateraTM by an analysis of the latest blood samples collected within 3 months prior to enrollment
  • Patients with no obvious relapse confirmed by chest, abdominal, and pelvic CT scans, etc.
  • Patients who are capable of oral ingestion
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  • Patients aged 20 years or older at the time of informed consent
  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  • Patients who have no severe disorder in major organs (such as the bone marrow, heart, lungs, liver, and kidneys) and meet the following criteria (Data obtained most recently and within 14 days of the date of enrollment will be used for enrollment. Data obtained 2 weeks before the date of enrollment, on the same day of the week as the enrollment date, may be used for enrollment.)
  • Neutrophil count ≥ 1,500/mm3
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin ≥ 8.0 g/dL
  • Serum creatinine ≤ 1.5 mg/dL
  • Total bilirubin ≤ 1.5 mg/dL
  • ALT and AST ≤ 100 U/L
  • Patients with no diarrhea or stomatitis of Grade 2 or severer according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
  • Patients who voluntarily gave written consent to participate in the trial after receiving a thorough explanation of the trial before enrolling in the trial

Who cannot join

  • Patients with a history of treatment with FTD/TPI
  • Patients with a history of treatment with 2 or more regimens of postoperative adjuvant chemotherapy (Preoperative chemotherapy will not be counted as a regimen.)
  • Patients with a past history of a malignant tumor
  • Patients with a local or systemic active infection requiring intervention
  • Patients who are positive for HBs antigen or positive for HCV antibody
  • Patients who are positive for HIV antibody (Patients who have not been tested for HIV antibody may be enrolled.)
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  • Patients with poorly controlled infections or diabetes
  • Patients with a past history of interstitial lung diseases (such as interstitial pneumonia and pulmonary fibrosis) requiring treatment or extensive findings of these diseases on CT
  • Patients with a serious complication
  • Patients who have been receiving systemic administration (oral or intravenous) of steroids (for 2 weeks or more at a dose of the equivalent of ≥ 10 mg/day of prednisolone)
  • Patients for whom enrollment in the trial is difficult because of clinically problematic psychiatric disorders
  • Pregnant or lactating women
  • Patients with reproductive potential who do not wish to use adequate contraceptive measures during the period of participation in the trial and during the contraception period
  • Patients who are judged by the attending physician to be ineligible for enrollment in the trial for other reasons

Trial locations and contacts

39 sites in 2 countries.

39 sites in 2 countries

Japan38 sites

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Bunkyo, Tokyo, 113-8677

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717

  • National Cancer Center Hospital

    Chūō, Tokyo, 104-0045

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

  • Gifu University Hospital

    Gifu, Gifu, 501-1194

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

  • Shimane Prefectural Central Hospital

    Izumo, Shimane, 693-8555

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • St. Marianna University School of Medicine Hospital

    Kawasaki, Kanagawa, 216-8511

  • Kagawa University Hospital

    Kita, Kagawa-ken, 761-0793

  • Hospital of the University of Occupational and Environmental Health

    Kitakyushu, Fukuoka, 807-8556

  • Sano Hospital

    Kobe, Hyōgo, 655-0031

  • Cancer Institute Hospital Of JFCR

    Koto, Tokyo, 135-8550

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-8556

  • University Hospital, Kyoto Prefectural Univercity of Medicine

    Kyoto, Kyoto, 602-8566

  • Kyoto-Katsura Hospital

    Kyoto, Kyoto, 615-8256

  • Aizawa Hospital

    Matsumoto, Nagano, 390-8510

  • Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Kyorin University Hospital

    Mitaka, Tokyo, 181-8611

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681

  • University of the Ryukyus Hospital

    Nakagami, Okinawa, 903-0215

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558

  • National Hospital Organization Osaka National Hospital

    Osaka, Osaka, 540-0006

  • Saitama Cancer Center

    Saitama, Saitama, 362-0806

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido, 060-8543

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Shizuoka Cancer Center

    Shizuoka, Shizuoka, 411-8777

  • Osaka University Hospital

    Suita, Osaka, 565-0871

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, Osaka, 569-8686

  • Toyama University Hospital

    Toyama, Toyama, 930-0194

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

  • University of Fukui Hospital

    Yoshida, Fukui, 910-1193

Other trials in Japan

Taiwan1 site

  • National Taiwan University Hospital

    Taipei, Taiwan, 100229

Other trials in Taiwan

About this study

Official title: A Randomized, Double-Blind, Phase III Study Comparing FTD/TPI Therapy Versus Placebo in Patients Who Are Positive for Blood Circulating Tumor DNA After Curative Resection of Colorectal Cancer

This trial is a randomized, double-blind, multinational Phase III study to evaluate the efficacy and safety of preemptive treatment with FTD/TPI compared with administration of placebo as follow-up, which is the standard of care, in patients who underwent curative resection of colorectal cancer and then tested positive for ctDNA.

Being tested
trifluridine and tipiracil, Placebo
Keywords
Colorectal Neoplasms, Gastrointestinal Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Antineoplastic Agents, trifluridine and tipiracil
Medical subject headings
Colorectal Neoplasms, Gastrointestinal Neoplasms, Digestive System Diseases, Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • trifluridine and tipiracilDrug

    Trifluridine and tipiracil will be orally administered twice daily on Days 1 to 5 and Days 8 to 12. The administration will be repeated until completion of 6 courses(one course consists of 28 days) or until any discontinuation criterion is met.

  • PlaceboDrug

    Placebo will be orally administered twice daily on Days 1 to 5 and Days 8 to 12. The administration will be repeated until completion of 6 courses(one course consists of 28 days) or until any discontinuation criterion is met.

Study groups in NCT04457297
Study groupRoleWhat they receive
trifluridine and tipiracilExperimentalNot described
Receives: Drug: trifluridine and tipiracil
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free Survival 1 (DFS1)

    The time from the date of enrollment to any of the following events, whichever occurs first: a relapse, the first development of a secondary colorectal cancer lesion other than a relapse and death from any cause.

    Measured: Up to 3 years

Secondary outcomes (5)

  1. Rate of Conversion to Negative ctDNA

    This rate is defined as the proportion of subjects who became negative for ctDNA at the test immediately after completion of study treatment.

    Measured: Up to 2 years

  2. Disease-free Survival 2 (DFS2)

    The time from the date of enrollment to any of the following events, whichever occurs first: a relapse, development of a cancer lesion other than a relapse (secondary cancer), and death from any cause. For survives with no evidence of recurrence, DFS2 data will be censored at the last imaging date of confirmed no recurrence. Subjects for which no imaging have been performed, DFS2 data will be censored at the date of enrollment.

    Measured: Up to 3 years

  3. Overall Survival (OS)

    The time from the date of enrollment to the date of death from any cause. In surviving subjects, the last date of confirmation of survival will be treated as the end of this period. In subjects lost to follow-up, the last date of confirmation of survival before loss to follow-up will be treated as the end of this period.

    Measured: Up to 3 years

  4. Treatment Completion Rate

    This rate had calculated for each eligible subject in accordance with the following equation: Treatment completion rate (%) = number of treatment courses completed/6 × 100

    Measured: Up to 3 years

  5. QOL (Week 24 Only)

    Measure Description:

    Quality of Life was assessed using two validated instruments:

    EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) evaluates cancer-specific HRQoL across domains:

    Global Health Status/QoL (range: 0-100, higher = better global health/QoL), Functional Scales (Physical, Role, Emotional, Cognitive, Social; each range: 0-100, higher = better functioning), Symptom Scales (Fatigue, Nausea/vomiting, Pain, Dyspnoea, Insomnia, Appetite loss, Constipation, Diarrhoea, Financial difficulties): each 0-100 (higher = worse/more severe symptoms).

    Scores are linearly transformed; subscales are reported individually (not summed).

    EQ-5D-5L (EuroQOL 5-Dimension 5-Level) measures general health across five dimensions:

    Index Score (range: -1.000 to 1.000, higher = better health), Visual Analogue Scale (VAS) (range: 0-100, higher = better health). Unit of Measure: scores on a scale. Note: Only Week 24 results are presented.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start8 Jul 2020
  3. Primary completion18 Jul 2024
  4. Study completion18 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
243 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04457297
Sponsor's protocol ID
EPOC 1905
Other IDs
JapicCTI-205363
Acronym
ALTAIR
Status last verified
Jan 2026
First submitted
25 Jun 2020
Last updated
21 Jan 2026
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bando H, Watanabe J, Takahashi Y, Kotaka M, Matsuhashi N, Oki E, Komatsu Y, Shiozawa M, Hirata K, Miyamoto Y, Takahashi M, Yamazaki K, Manaka D, Kanazawa A, Liang YH, Yeh KH, Watsuji Y, Yamamoto Y, Fukui M, Sharma S, Aushev VN, Jurdi A, Rabinowitz M, Liu MC, Aleshin A, Takemasa I, Kotani D, Sato A, Misumi T, Nakamura Y, Shi Q, Taniguchi H, Yoshino T, Kato T. Post-adjuvant chemotherapy in ctDNA-positive patients with resected colorectal cancer: a randomized phase 3 trial. Nat Med. 2026 Jul;32(7):2473-2480. doi: 10.1038/s41591-026-04428-0. Epub 2026 Jun 8.

    PubMed 42260101

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing trifluridine and tipiracil in people with Colorectal Neoplasms and Trifluridine and Tipiracil, run by National Cancer Center Hospital East at 39 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Japan, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free Survival 1 (DFS1) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04457297, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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ALTAIR Clinical Trial NCT04457297 | AzTrials