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

NCT ID NCT04457297

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

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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