Study of ctDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas (NCT04920032) | Clinical Trial Compass
RecruitingPhase 1
Study of ctDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas
United States22 participantsStarted 2021-08-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must have histologically or cytologically confirmed adenocarcinoma of the colon (high rectal cancer is eligible if resected and no radiation needed). Other histologies which are treated per NCCN guidelines for adjuvant colon cancer are eligible.
✓. Must have Stage II, Stage III, or Stage IV colorectal cancer after curative intent resection eligible for adjuvant doublet chemotherapy for at least 3 months.
✓. Must have ctDNA positive assay (tested by Signatera MRD assay) after at least 3 months of perioperative chemotherapy
✓. Age ≥ 18 years
✓. Performance status: ECOG performance status ≤2
✓. Life expectancy of greater than 3 months
✓. Adequate organ and marrow function as defined below:
✓. leukocytesL ≥ 3,000/mcL
Exclusion criteria
✕. Patients who have had major surgery within 4 weeks, or chemotherapy or radiotherapy within 2 weeks prior to Cycle 1 Day 1
✕. All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to grade 1 or baseline
✕. Patients may not be receiving any other investigational agents.
✕. Patients with known metastases.
What they're measuring
1
Percentage of ctDNA positivity in treatment cohort after 6 cycles or at least 3 months of adjuvant treatment
Timeframe: 6 months
Trial details
NCT IDNCT04920032
SponsorUniversity of California, Irvine
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-01-21
Contact for this trial
Chao Family Comprehensive Cancer Center University of California, Irvine
. History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS-102, irinotecan or other agents used in study.
✕. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
✕. Prior treatment with TAS-102 at any time or irinotecan within 90 days from enrollment.
✕. History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ.