RecruitingPhase 1NCT04920032

Study of ctDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas

Proof of Concept Study of ctDNA Guided Change in Treatment for Refractory Minimal Residual Disease in Colon Adenocarcinomas

Sponsor

University of California, Irvine

Enrollment

22 participants

Start Date

Aug 26, 2021

Study Type

INTERVENTIONAL

Conditions

Colon Adenocarcinoma

Summary

This is a phase 1b, prospective, single arm, non-randomized, open-label clinical trial determining the efficacy of adjuvant trifluridine and tipiracil (TAS-102) in combination with irinotecan in patients with ctDNA positive colon adenocarcinoma.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether switching colon cancer patients to a different chemotherapy drug (TAS-102 or irinotecan) when their cancer DNA is still detectable in the blood after surgery and initial chemotherapy can improve cure rates. **You may be eligible if:** - You are 18 or older and have had colon cancer (stage II, III, or IV) surgically removed with the intent to cure - You have received at least 3 months of chemotherapy after surgery, but cancer DNA is still detectable in your blood (using the Signatera test) - Your overall health is good enough to continue chemotherapy - You can swallow tablets **You may NOT be eligible if:** - You have known distant spread of cancer (metastases) - You have had TAS-102 or irinotecan previously - You have recently had major surgery or chemotherapy (within the last 2–4 weeks) - You have severe uncontrolled illness or significant heart problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTAS-102

Given PO

DRUGIrinotecan

Given IV

COMBINATION_PRODUCTStandard Treatment

6 cycles for a 2-week regimen (infusional 5FU based) and up to 4 cycles for a 3-week regimen (oral capecitabine based) after randomization

DIAGNOSTIC_TESTSignatera MRD ctDNA Assay

To be performed within 6-8 weeks of Cycle 1 Day 1. A Mid-treatment ctDNA is to be completed within 6 - 8 weeks of starting treatment. ctDNA is to also be completed within four weeks after completion of study treatment (+/- two weeks)