Trial · NCT04457297

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

NCT04457297, Phase 3, Completed, National Cancer Center Hospital East; results first posted 2026-01-21

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. Initial Attack on Latent Metastasis Using TAS-102 for ct DNA Identified Colorectal Cancer Patients After Curative Resection. Trials, record NCT04457297. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04457297

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Initial Attack on Latent Metastasis Using TAS-102 for ct DNA Identified Colorectal Cancer Patients After Curative Resection
NCT number: NCT04457297
Status: Completed
Phases: Phase 3
Enrollment: 243 participants, actual
Lead sponsor: National Cancer Center Hospital East
Conditions: Colorectal Neoplasms, Trifluridine and Tipiracil, Circulating Tumor DNA
Interventions: trifluridine and tipiracil, Placebo
First posted: 2020-07-07
Last updated: 2026-01-21
Results first posted: 2026-01-21

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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, the first development of a secondary colorectal cancer lesion other than a relapse and death from any cause.
Secondary	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.
Secondary	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. For survives with no evidence of recurrence, DFS2 data will be censored at the last imaging date of confirmed no recurrence. Subjects for which no imaging have been performed, DFS2 data will be censored at the date of enrollment.
Secondary	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.
Secondary	Treatment Completion Rate	Up to 3 years	This rate had calculated for each eligible subject in accordance with the following equation: Treatment completion rate (%) = number of treatment courses completed/6 × 100
Secondary	QOL (Week 24 Only)	Up to 1 year	Measure Description: Quality of Life was assessed using two validated instruments: EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) evaluates cancer-specific HRQoL across domains: Global Health Status/QoL (range: 0-100, higher = better global health/QoL), Functional Scales (Physical, Role, Emotional, Cognitive, Social; each range: 0-100, higher = better functioning), Symptom Scales (Fatigue, Nausea/vomiting, Pain, Dyspnoea, Insomnia, Appetite loss, Constipation, Diarrhoea, Financial difficulties): each 0-100 (higher = worse/more severe symptoms). Scores are linearly transformed; subscales are reported individually (not summed). EQ-5D-5L (EuroQOL 5-Dimension 5-Level) measures general health across five dimensions: Index Score (range: -1.000 to 1.000, higher = better health), Visual Analogue Scale (VAS) (range: 0-100, higher = better health). Unit of Measure: scores on a scale. Note: Only Week 24 results are presented.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease-free Survival 1 (DFS1)	Up to 3 years	Disease free survival 1 (DFS1) was assessed in Full Analysis Set.	Months	MEDIAN
SECONDARY	Rate of Conversion to Negative ctDNA	Up to 2 years	Rate of Conversion to Negative ctDNA was assessed in Full Analysis Set.	Percentage	NUMBER
SECONDARY	Disease-free Survival 2 (DFS2)	Up to 3 years	Disease free survival 2 (DFS2) was assessed in Full Analysis Set.	Months	MEDIAN
SECONDARY	Overall Survival (OS)	Up to 3 years	Overall survival (OS) was assessed in Full Analysis Set.	Months	MEDIAN
SECONDARY	Treatment Completion Rate	Up to 3 years	Treatment completion rate was assessed in Full Analysis Set.	Percentage of treatment completion	MEAN
SECONDARY	QOL (Week 24 Only)	Up to 1 year	QOL was assessed in Full Analysis Set.	scores on a scale	MEAN

Source ClinicalTrials.gov

Results by group44

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Disease-free Survival 1 (DFS1)	Trifluridine and Tipiracil	9.30	95% Confidence Interval 7.82 to 10.84	Months
Disease-free Survival 1 (DFS1)	Placebo	5.55	95% Confidence Interval 4.17 to 6.47	Months
Rate of Conversion to Negative ctDNA	Trifluridine and Tipiracil	17.2	95% Confidence Interval 11.0 to 25.1	Percentage
Rate of Conversion to Negative ctDNA	Placebo	12.4	95% Confidence Interval 7.1 to 19.6	Percentage
Disease-free Survival 2 (DFS2)	Trifluridine and Tipiracil	9.30	95% Confidence Interval 7.82 to 10.84	Months
Disease-free Survival 2 (DFS2)	Placebo	5.55	95% Confidence Interval 4.17 to 6.47	Months
Overall Survival (OS)	Trifluridine and Tipiracil	NA	95% Confidence Interval NA to NA	Months
Overall Survival (OS)	Placebo	37.26	95% Confidence Interval NA to NA	Months
Treatment Completion Rate	Trifluridine and Tipiracil	77.87	Standard Deviation 30.26	Percentage of treatment completion
Treatment Completion Rate	Placebo	78.79	Standard Deviation 25.46	Percentage of treatment completion

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Trifluridine and Tipiracil	122
Overall Study	STARTED	Placebo	121
Overall Study	COMPLETED	Trifluridine and Tipiracil	122
Overall Study	COMPLETED	Placebo	121
Overall Study	NOT COMPLETED	Trifluridine and Tipiracil	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events54

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Trifluridine and Tipiracil	32	122
other	Anaemia	Blood and lymphatic system disorders	Placebo	2	121
other	Neutropenia	Blood and lymphatic system disorders	Trifluridine and Tipiracil	15	122
other	Neutropenia	Blood and lymphatic system disorders	Placebo	0	121
other	Decreased appetite	Metabolism and nutrition disorders	Trifluridine and Tipiracil	27	122
other	Decreased appetite	Metabolism and nutrition disorders	Placebo	2	121
other	Dysgeusia	Nervous system disorders	Trifluridine and Tipiracil	10	122
other	Dysgeusia	Nervous system disorders	Placebo	1	121
other	Headache	Nervous system disorders	Trifluridine and Tipiracil	7	122
other	Headache	Nervous system disorders	Placebo	2	121

1 to 10 of 54Source ClinicalTrials.gov

See all 54 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Trifluridine and Tipiracil	0	122
Total, all-cause mortality	Placebo	0	121
Total, other adverse events	Trifluridine and Tipiracil	120	122
Total, other adverse events	Placebo	69	121
Total, serious adverse events	Trifluridine and Tipiracil	6	122
Total, serious adverse events	Placebo	0	121

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
42260101	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Trifluridine and Tipiracil vs Placebo: deaths from any cause	Trial comparisons
Trifluridine and Tipiracil vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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