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

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT04920032
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TAS-102 — DRUG
    Given PO
  • Irinotecan — DRUG
    Given IV
  • Standard Treatment — COMBINATION_PRODUCT
    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
  • Signatera MRD ctDNA Assay — DIAGNOSTIC_TEST
    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)

Study Details

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.

Key Dates

Start date
Aug 26, 2021
Status verified
May 2026
Primary completion
Jan 21, 2027
Completion
Jan 21, 2028

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TASIRI
    Patients randomized to the experimental arm ("TASIRI") will be treated with TAS-102 25mg/m2 p.o. on days 1-5 and irinotecan 180mg/m2 i.v. on day 1 every 14 days. If ANC \<1500/uL on day 1 of a cycle, then G-CSF will be added on day 6 for three days.

Primary Outcome Measure

Percentage of ctDNA positivity in treatment cohort after 6 cycles or at least 3 months of adjuvant treatment [ Time Frame: 6 months ]

Central Contacts

  • Chao Family Comprehensive Cancer Center University of California, Irvine
    1-877-827-7883
    [email protected]
  • University of California Irvine Medical

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center, University of California, IrvineOrangeCalifornia92868
Farshid Dayyani, MD, PhD
[email protected]
877-827-8839

Find similar trials in Orange, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Chao Family Comprehensive Cancer Center, University of California, Irvine· Orange, CA

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