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

NCT04457297 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2026-01-21

Study results available
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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

Interventions

DRUG

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.

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.

Sponsors & Collaborators

  • Alpha-A, Inc.

    collaborator UNKNOWN

  • National Cancer Center Hospital East

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-08
Primary Completion
2024-07-18
Completion
2024-07-18

Countries

  • Japan
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04457297 on ClinicalTrials.gov