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

NCT ID: NCT04457297

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-08
• Study Completion Date: 2024-07-18

Brief 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 positive for ctDNA.

Conditions

Colorectal Neoplasms; Trifluridine and Tipiracil; Circulating Tumor DNA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

trifluridine and tipiracil

Group Type: EXPERIMENTAL

trifluridine and tipiracil

Intervention Type: DRUG

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.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

trifluridine and tipiracil

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alpha-A, Inc.

UNKNOWN

Sponsor Role: collaborator

National Cancer Center Hospital East

OTHER

Sponsor Role: lead

Responsible Party

Takayuki Yoshino

MD., PhD Head of Department of Gastroenterology and Gastrointestinal Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Chiba Cancer Center

Chiba, Chiba, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Shikoku Cancer Center

Matsuyama, Ehime, Japan

University of Fukui Hospital

Yoshida, Fukui, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Hospital of the University of Occupational and Environmental Health

Kitakyushu, Fukuoka, Japan

Gifu University Hospital

Gifu, Gifu, Japan

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Sano Hospital

Kobe, Hyōgo, Japan

University of Tsukuba Hospital

Tsukuba, Ibaraki, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Kagawa University Hospital

Kita, Kagawa-ken, Japan

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, Japan

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

University Hospital, Kyoto Prefectural Univercity of Medicine

Kyoto, Kyoto, Japan

Kyoto-Katsura Hospital

Kyoto, Kyoto, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Aizawa Hospital

Matsumoto, Nagano, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

University of the Ryukyus Hospital

Nakagami, Okinawa, Japan

Kansai Medical University Hospital

Hirakata, Osaka, Japan

National Hospital Organization Osaka National Hospital

Osaka, Osaka, Japan

Osaka University Hospital

Suita, Osaka, Japan

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka, Japan

Saitama Cancer Center

Saitama, Saitama, Japan

Shimane Prefectural Central Hospital

Izumo, Shimane, Japan

Shizuoka Cancer Center

Shizuoka, Shizuoka, Japan

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyo, Tokyo, Japan

National Cancer Center Hospital

Chūō, Tokyo, Japan

Cancer Institute Hospital Of JFCR

Koto, Tokyo, Japan

Kyorin University Hospital

Mitaka, Tokyo, Japan

Toyama University Hospital

Toyama, Toyama, Japan

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Countries

Japan; Taiwan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

JapicCTI-205363

Identifier Type: REGISTRY

Identifier Source: secondary_id

EPOC 1905

Identifier Type: -

Identifier Source: org_study_id