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

STATUS

Recruiting
participants needed

240
sponsor

National Cancer Center Hospital East

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Updated on 19 February 2024

See if I qualify

platelet count

ct scan

metastasis

neutrophil count

adenocarcinoma

diarrhea

colon cancer

colorectal adenocarcinoma

tas-102

trifluridine/tipiracil

colorectal cancer

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.

Details

Condition	Colorectal Cancer, Colorectal Cancer, Rectal disorder, Circulating Tumor DNA, Trifluridine and Tipiracil
Age	20-100 years
Treatment	Placebo, trifluridine and tipiracil
Clinical Study Identifier	NCT04457297
Sponsor	National Cancer Center Hospital East
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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 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 by an analysis of blood samples using SignateraTM within 2 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
	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
Exclusion Criteria
	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

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