Initial Attack on Latent Metastasis Using TAS-102 for ct DNA Identified Colorectal Cancer Patients After Curative Resection
- Conditions
- Colorectal NeoplasmsTrifluridine and TipiracilCirculating Tumor DNA
- Interventions
- Drug: trifluridine and tipiracilDrug: Placebo
- Registration Number
- NCT04457297
- Lead Sponsor
- National Cancer Center Hospital East
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
-
Patients who have been histopathologically diagnosed with colorectal adenocarcinoma
-
Patients who have undergone radical curative resection of the primary and metastatic tumors
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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
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Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
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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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description trifluridine and tipiracil trifluridine and tipiracil - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Disease-free survival 1 (DFS1) Up to 3 years The time from the date of enrollment to any of the following events, whichever occurs first: a relapse, development of a secondary colorectal cancer lesion other than a relapse and death from any cause.
- Secondary Outcome Measures
Name Time Method Rate of Conversion to Negative ctDNA Up to 2 years This rate is defined as the proportion of subjects who became negative for ctDNA at the test immediately after completion of study treatment.
Overall Survival (OS) Up to 3 years 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.
Disease-free survival 2 (DFS2) Up to 3 years 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. In surviving subjects who have not been judged to have a relapse, the last date of survival with confirmation of no relapse be treated as the end of this period.
Incidence of Adverse Events Up to 3 years For each of the AEs due to the following study treatment, the frequency of cases with the worst grade in all courses according to CTCAE v5.0 will be calculated using all treated patients as the denominator.
Treatment Completion Rate Up to 3 years This rate will be calculated for each eligible subject in accordance with the following equation. Treatment completion rate (%) = number of treatment courses completed/6 × 100
Trial Locations
- Locations (39)
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Sapporo Medical University Hospital
🇯🇵Sapporo, Hokkaido, Japan
University of Tsukuba Hospital
🇯🇵Tsukuba, Ibaraki, Japan
Kanazawa University Hospital
🇯🇵Kanazawa, Ishikawa, Japan
St. Marianna University School of Medicine Hospital
🇯🇵Kawasaki, Kanagawa, Japan
Kagawa University Hospital
🇯🇵Kita, Kagawa, Japan
Tohoku University Hospital
🇯🇵Sendai, Miyagi, Japan
Aizawa Hospital
🇯🇵Matsumoto, Nagano, Japan
University of the Ryukyus Hospital
🇯🇵Nakagami, Okinawa, Japan
Kansai Medical University Hospital
🇯🇵Hirakata, Osaka, Japan
Osaka University Hospital
🇯🇵Suita, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
🇯🇵Takatsuki, Osaka, Japan
Shimane Prefectural Central Hospital
🇯🇵Izumo, Shimane, Japan
Kyorin University Hospital
🇯🇵Mitaka, Tokyo, Japan
Chiba Cancer Center
🇯🇵Chiba, Japan
National Hospital Organization Kyushu Cancer Center
🇯🇵Fukuoka, Japan
Gifu University Hospital
🇯🇵Gifu, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
University Hospital, Kyoto Prefectural Univercity of Medicine
🇯🇵Kyoto, Japan
National Hospital Organization Osaka National Hospital
🇯🇵Osaka, Japan
Saitama Cancer Center
🇯🇵Saitama, Japan
Shizuoka Cancer Center
🇯🇵Shizuoka, Japan
Toyama University Hospital
🇯🇵Toyama, Japan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
University of Fukui Hospital
🇯🇵Yoshida, Fukui, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
Hospital of the University of Occupational and Environmental Health
🇯🇵Kitakyushu, Fukuoka, Japan
National Cancer Center Hospital
🇯🇵Chuo, Tokyo, Japan
Aichi Cancer Center Hospital
🇯🇵Nagoya, Aichi, Japan
Shikoku Cancer Center
🇯🇵Matsuyama, Ehime, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Sano Hospital
🇯🇵Kobe, Hyogo, Japan
Yokohama City University Medical Center
🇯🇵Yokohama, Kanagawa, Japan
Kanagawa Cancer Center
🇯🇵Yokohama, Kanagawa, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
🇯🇵Bunkyo, Tokyo, Japan
Cancer Institute Hospital Of JFCR
🇯🇵Koto, Tokyo, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Kyoto-Katsura Hospital
🇯🇵Kyoto, Japan