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New treatment option for Colorectal Cancer
Official title TAS-102 With or Without Celecoxib in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy
ClinicalTrials.gov ID: NCT05343013
What this study is testing
What is TAS-102?
TAS-102 is an investigational medicine, being studied as a potential treatment for colorectal cancer.
Also referred to as trifluridine, tipiracil.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
- Has adequate organ and marrow function as defined below:
You likely can't join 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...
- Has significant concomitant health conditions including but not limited to severe autoimmune or cardiovascular disorders that may interfere with...
- Has a persistent adverse event, except alopecia and neuropathy, greater than or equal to grade 2 of the Common Toxicity Criteria for Adverse Events...
- Has another disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition that investigators suspect...
- 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...
See the full eligibility criteria
- 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...
- 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) =...
- 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 people 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.