NCT05343013

Brief Summary

To measure the level of circulating tumor DNA (ctDNA) in the blood of colorectal cancer patients after 6 months of receiving TAS-102 therapy. ctDNA is genetic material from tumor cells that can be found and measured in the blood.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2 colorectal-cancer

Timeline
12mo left

Started Jun 2022

Typical duration for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jun 2022May 2027

First Submitted

Initial submission to the registry

April 15, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 6, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2027

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

4.9 years

First QC Date

April 15, 2022

Last Update Submit

March 4, 2026

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • To determine the 6-month ctDNA clearance rate in colorectal cancer patients with minimal residual disease following 6 months of TAS-102 therapy.

    up to 6 months

Study Arms (1)

TAS-102

EXPERIMENTAL

TAS-102 should be taken by mouth 2 times a day, within 1 hour after your morning and evening meals (about 12 hours apart).

Drug: TAS-102

Interventions

TAS-102DRUG

GIven by PO

Also known as: trifluridine, tipiracil, Lonsurf
TAS-102

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has histological confirmation of colorectal cancer
  • Received post-R0 resection of stages II, III, or IV colorectal cancer and has completed all planned curative intent therapies that must include ≥ 3 months of oxaliplatin containing chemotherapy
  • Has no definitive evidence of radiographic disease per assessment by investigators within 28 days (before or after) a positive ctDNA assay
  • Has minimal residual disease as defined by positive ctDNA assay (completed as standard-of-care at MD Anderson). Patients may be identified for enrollment with any Clinical Laboratory Improvement Amendments (CLIA)-certified ctDNA assay for MRD. MRD status will be confirmed with the Signatera assay prior to initiation of therapy (unless the prior testing was also done with Signatera in which case this test would not require confirmation)
  • Has adequate organ and marrow function as defined below:
  • absolute neutrophil count: ≥1,000/mcL
  • platelets: ≥100,000/mcL
  • total bilirubin: ≤ institutional upper limit of normal (ULN)
  • AST(SGOT)/ALT(SGPT): ≤3 × institutional ULN
  • Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥60 mL/min. Creatinine clearance (Clcr) can either be measured in a 24-hour urine collection or estimated by the Cockcroft-Gault equation as follows: Clcr (mL/min) = \[(140 - age) x (weight in kg) ÷ \[72 x (serum creatinine in mg/dL)\] \[0.85 if female\]
  • Has ECOG performance status (PS) of 0 or 1
  • Is of age ≥ 18 years. Because no dosing or adverse-event data are currently available on the use of TAS-102 in patients, children \<18 years of age are excluded from this study.
  • Is able to understand and is willing to sign a written informed consent document.
  • Is willing to utilize contraception. Female subjects agree to use highly effective contraception combined with an additional barrier method (eg, diaphragm, with a spermicide) while on study and for 7 months after last dose of study drug, and the same criteria are applicable to male subjects if they have a partner of childbirth potential. Male subject agrees to use a condom and not donate sperm while in this study and for 7 months after the last treatment.

You may not qualify if:

  • Has other concomitant active, invasive malignancies that may interfere with ctDNA analysis (known clonal hematopoesis of unknown potential allowed)
  • Has serum electrolytes, potassium, calcium, or magnesium levels outside of the normal laboratory reference range which are clinically significant in the investigator's judgment
  • Has significant concomitant health conditions including but not limited to severe autoimmune or cardiovascular disorders that may interfere with participation in the study per assessment by investigators
  • Has a persistent adverse event, except alopecia and neuropathy, greater than or equal to grade 2 of the Common Toxicity Criteria for Adverse Events (CTCAE) v. 5.0
  • Has another disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition that investigators suspect may (a) prohibit use of the investigational product, (b) affect interpretation of study results, or (c) put the patient at undue risk of harm
  • Has known hypersensitivity to the trial drugs or their excipients or is at risk of allergic of anaphylactic reaction to drug product according to the Investigator's judgement
  • Is pregnant or lactating
  • Is unable to take medication orally or has any other condition that investigators believe may affect absorption of the investigational product
  • Is receiving any other investigational agent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

  • Pellatt AJ, Bent A, Hornstein N, Parseghian C, Huey R, Raghav K, Morris V, Overman M, Morelli P, Willis J, Le P, Shen JP, Kee B, Eluri M, Higbie V, Alfaro-Munoz K, Aziz K, Kell R, Sun R, Kopetz S, Dasari A. Phase II Trial of TAS-102 in Colorectal Cancer Patients With Circulating Tumor DNA-Defined Minimal Residual Disease After Adjuvant Therapy: INTERCEPT-TT. JCO Precis Oncol. 2025 Jul;9:e2500142. doi: 10.1200/PO-25-00142. Epub 2025 Jul 16.

    PMID: 40669021DERIVED

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

trifluridine tipiracil drug combinationTrifluridinetipiracil

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Alisha Bent, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Central Study Contacts

Alisha Bent, MD

CONTACT

(713) 745-2744giclinicaltrials@mdanderson.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2022

First Posted

April 25, 2022

Study Start

June 6, 2022

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

May 15, 2027

Last Updated

March 6, 2026

Record last verified: 2026-03

Locations

US(1)