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Can a pill stop Cancer's return? new trial targets hidden DNA signals

NCT ID NCT04457297

Disease control Sponsor: National Cancer Center Hospital East Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 study tested the drug FTD/TPI (a chemotherapy pill) against a placebo in 243 people who had surgery for colorectal cancer but still had cancer DNA in their blood. The goal was to see if the drug could prevent the cancer from coming back. Participants took the drug or placebo for up to 6 months, and researchers tracked relapse rates.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trifluridine and tipiracil (FTD/TPI)
What this could lead to
If it works, this could help prevent colorectal cancer from coming back after surgery in patients with signs of remaining cancer DNA in their blood.
What could go wrong
This is a completed Phase 3 trial, but results are not yet widely known. The drug may not improve survival and can cause side effects like low blood counts or fatigue.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

243 people

The number who actually took part.

Started

Jul 2020

Finished

Jul 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients who have been histopathologically diagnosed with colorectal adenocarcinoma 2. Patients who have undergone radical curative resection of the primary and metastatic tumors 3. 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 4. Patients who tested positive for ctDNA using SignateraTM by an analysis of the latest blood samples collected within 3 months prior to enrollment 5. Patients with no obvious relapse confirmed by chest, abdominal, and pelvic CT scans, etc. 6. Patients who are capable of oral ingestion 7. Patients aged 20 years or older at the time of informed consent 8. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 9. 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 10. Patients with no diarrhea or stomatitis of Grade 2 or severer according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 11. Patients who voluntarily gave written consent to participate in the trial after receiving a thorough explanation of the trial before enrolling in the trial Exclusion Criteria: 1. Patients with a history of treatment with FTD/TPI 2. Patients with a history of treatment with 2 or more regimens of postoperative adjuvant chemotherapy (Preoperative chemotherapy will not be counted as a regimen.) 3. Patients with a past history of a malignant tumor 4. Patients with a local or systemic active infection requiring intervention 5. Patients who are positive for HBs antigen or positive for HCV antibody 6. Patients who are positive for HIV antibody (Patients who have not been tested for HIV antibody may be enrolled.) 7. Patients with poorly controlled infections or diabetes 8. 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 9. Patients with a serious complication 10. 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) 11. Patients for whom enrollment in the trial is difficult because of clinically problematic psychiatric disorders 12. Pregnant or lactating women 13. 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 14. Patients who are judged by the attending physician to be ineligible for enrollment in the trial for other reasons

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Conditions

The condition(s) this trial relates to.

colorectal adenocarcinoma colorectal neoplasm Digestive System Diseases digestive system disorder digestive system neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Circulating tumor DNA Colorectal neoplasms Trifluridine and tipiracil

Contacts and locations

Locations

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681, Japan

  • Aizawa Hospital

    Matsumoto, Nagano, 390-8510, Japan

  • Cancer Institute Hospital Of JFCR

    Koto, Tokyo, 135-8550, Japan

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717, Japan

  • Gifu University Hospital

    Gifu, Gifu, 501-1194, Japan

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551, Japan

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

  • Hospital of the University of Occupational and Environmental Health

    Kitakyushu, Fukuoka, 807-8556, Japan

  • Kagawa University Hospital

    Kita, Kagawa-ken, 761-0793, Japan

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515, Japan

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191, Japan

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-8556, Japan

  • Kyorin University Hospital

    Mitaka, Tokyo, 181-8611, Japan

  • Kyoto-Katsura Hospital

    Kyoto, Kyoto, 615-8256, Japan

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582, Japan

  • National Cancer Center Hospital

    Chūō, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577, Japan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395, Japan

  • National Hospital Organization Osaka National Hospital

    Osaka, Osaka, 540-0006, Japan

  • National Taiwan University Hospital

    Taipei, Taiwan, 100229, Taiwan

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558, Japan

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, Osaka, 569-8686, Japan

  • Osaka University Hospital

    Suita, Osaka, 565-0871, Japan

  • Saitama Cancer Center

    Saitama, Saitama, 362-0806, Japan

  • Sano Hospital

    Kobe, Hyōgo, 655-0031, Japan

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido, 060-8543, Japan

  • Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280, Japan

  • Shimane Prefectural Central Hospital

    Izumo, Shimane, 693-8555, Japan

  • Shizuoka Cancer Center

    Shizuoka, Shizuoka, 411-8777, Japan

  • St. Marianna University School of Medicine Hospital

    Kawasaki, Kanagawa, 216-8511, Japan

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Bunkyo, Tokyo, 113-8677, Japan

  • Toyama University Hospital

    Toyama, Toyama, 930-0194, Japan

  • University Hospital, Kyoto Prefectural Univercity of Medicine

    Kyoto, Kyoto, 602-8566, Japan

  • University of Fukui Hospital

    Yoshida, Fukui, 910-1193, Japan

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576, Japan

  • University of the Ryukyus Hospital

    Nakagami, Okinawa, 903-0215, Japan

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024, Japan

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