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

NCT04457297 | Completed Phase 3 Results

• 2 other identifiers: EPOC 1905JapicCTI-205363
• Study Type: interventional
• Target: 243
• Locations: 2 countries
• Sites: 39

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

Trifluridine and Tipiracil; Circulating Tumor DNA; Colorectal Neoplasms

Keywords

Colorectal Neoplasms; Gastrointestinal Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Antineoplastic Agents; trifluridine and tipiracil

Outcome Measures

Primary Outcomes (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.

  Up to 3 years

Secondary Outcomes (5)

• Rate of Conversion to Negative ctDNA

  Up to 2 years

• Disease-free Survival 2 (DFS2)

  Up to 3 years

• Overall Survival (OS)

  Up to 3 years

• Treatment Completion Rate

  Up to 3 years

• QOL (Week 24 Only)

  Up to 1 year

Study Arms (2)

trifluridine and tipiracil

EXPERIMENTAL

Drug: trifluridine and tipiracil

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo 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.

Placebo

trifluridine and tipiracil 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.

trifluridine and tipiracil

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.)
• 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

Sponsors & Collaborators

• Alpha-A, Inc.: collaborator
• National Cancer Center Hospital East: lead

Study Sites (39)

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, 464-8681, Japan

Location

Chiba Cancer Center

Chiba, Chiba, 260-8717, Japan

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

Shikoku Cancer Center

Matsuyama, Ehime, 791-0280, Japan

Location

University of Fukui Hospital

Yoshida, Fukui, 910-1193, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, Fukuoka, 811-1395, Japan

Location

Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582, Japan

Location

Hospital of the University of Occupational and Environmental Health

Kitakyushu, Fukuoka, 807-8556, Japan

Location

Gifu University Hospital

Gifu, Gifu, 501-1194, Japan

Location

Hiroshima University Hospital

Hiroshima, Hiroshima, 734-8551, Japan

Location

Sapporo Medical University Hospital

Sapporo, Hokkaido, 060-8543, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Sano Hospital

Kobe, Hyōgo, 655-0031, Japan

Location

University of Tsukuba Hospital

Tsukuba, Ibaraki, 305-8576, Japan

Location

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Kagawa University Hospital

Kita, Kagawa-ken, 761-0793, Japan

Location

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, 216-8511, Japan

Location

Yokohama City University Medical Center

Yokohama, Kanagawa, 232-0024, Japan

Location

Kanagawa Cancer Center

Yokohama, Kanagawa, 241-8515, Japan

Location

Kumamoto University Hospital

Kumamoto, Kumamoto, 860-8556, Japan

Location

University Hospital, Kyoto Prefectural Univercity of Medicine

Kyoto, Kyoto, 602-8566, Japan

Location

Kyoto-Katsura Hospital

Kyoto, Kyoto, 615-8256, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

Location

Aizawa Hospital

Matsumoto, Nagano, 390-8510, Japan

Location

Okayama University Hospital

Okayama, Okayama-ken, 700-8558, Japan

Location

University of the Ryukyus Hospital

Nakagami, Okinawa, 903-0215, Japan

Location

Kansai Medical University Hospital

Hirakata, Osaka, 573-1191, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, Osaka, 540-0006, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka, 569-8686, Japan

Location

Saitama Cancer Center

Saitama, Saitama, 362-0806, Japan

Location

Shimane Prefectural Central Hospital

Izumo, Shimane, 693-8555, Japan

Location

Shizuoka Cancer Center

Shizuoka, Shizuoka, 411-8777, Japan

Location

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyo, Tokyo, 113-8677, Japan

Location

National Cancer Center Hospital

Chūō, Tokyo, 104-0045, Japan

Location

Cancer Institute Hospital Of JFCR

Koto, Tokyo, 135-8550, Japan

Location

Kyorin University Hospital

Mitaka, Tokyo, 181-8611, Japan

Location

Toyama University Hospital

Toyama, Toyama, 930-0194, Japan

Location

National Taiwan University Hospital

Taipei, Taiwan, 100229, Taiwan

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Gastrointestinal Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Interventions

trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Takayuki Yoshino
• Organization: National Cancer Center Hospital East

prj-altair_core@eps.co.jp

+81-4-7133-1111

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD., PhD Head of Department of Gastroenterology and Gastrointestinal Oncology

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 7, 2020
• Study Start: July 8, 2020
• Primary Completion: July 18, 2024
• Study Completion: July 18, 2024
• Last Updated: January 21, 2026
• Results First Posted: January 21, 2026

Record last verified: 2026-01

Locations

TW (1); JP (38)