Utility of ctDNA in Early Switch of First-line mFOLFIRINOX in Metastatic Pancreatic Ductal Adenocarcinoma

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07096362
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • 5-Fluorouracil — DRUG
    Participants will be administered 2400 mg/m\^2 of 5-Fluorouracil via continuous intravenous infusion over a 46-hour period beginning on Day 1 of each two-week cycle of standard of care (SOC) modified Folfirinox combination therapy.
  • Oxaliplatin — DRUG
    Participants will be administered 85 mg/m\^2 of Oxaliplatin via intravenous infusion beginning on Day 1 of each two-week cycle of standard of care (SOC) modified Folfirinox combination therapy.
  • Leucovorin — DRUG
    Participants will be administered 400 mg/m\^2 of Leucovorin via intravenous infusion beginning on Day 1 of each two-week cycle of standard of care (SOC) modified Folfirinox combination therapy.
  • Irinotecan — DRUG
    Participants will be administered 150 mg/m\^2 of Irinotecan via intravenous infusion beginning on Day 1 of each two-week cycle of standard of care (SOC) modified Folfirinox combination therapy.
  • Gemcitabine — DRUG
    Participants will be administered 1000 mg/m\^2 of Gemcitabine standard of care (SOC) via intravenous infusion on days 1, 8 and 15 of each four-week treatment cycle.
  • Nab Paclitaxel — DRUG
    Participants will be administered 125 mg/m\^2 of Nab Paclitaxel standard of care (SOC) by intravenous infusion on days 1, 8 and 15 of each four-week treatment cycle.
  • Circulating Tumor Deoxyribonucleic acid (ctDNA) Assay — DIAGNOSTIC_TEST
    ctDNA will be measured in participants in person via blood samples during Screening/Baseline and at the following intervals during treatment and follow-up: * Every weeks 2 beginning at weeks 2, 4, 6 and 8 of standard of care therapy. * Every 4 weeks beginning at week 10 of standard of care therapy until disease progression. ctDNA will be measured to obtain participant tumor methylation scores (TMS).

Study Details

The purpose of this study is to understand whether a blood-based test called circulating tumor DNA (ctDNA) can detect whether participants are having a desired tumor shrinkage or an undesired lack of tumor shrinkage, and to study whether these levels of ctDNA can be used to make treatment decisions faster than the current standard approach, which is to wait 8 weeks after starting chemotherapy to obtain participant first imaging scans since starting chemotherapy.

Key Dates

Start date
Sep 9, 2025
Status verified
Sep 2025
Primary completion
Sep 30, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Early Switch of Chemotherapy Interventional Cohort
    Participants in this group will receive ctDNA monitoring in combination with standard of care (SOC) of 5-fluorouracil, leucovorin, irinotecan, oxaliplatin (mFOLFIRINOX). Participants will receive standard of care treatment for up to 8 months. Total participation duration is approximately 18 months.
  • Active Comparator: Part 2 Arm A: Early Switch of Chemotherapy Interventional Cohort
    Participants in this group will receive ctDNA monitoring in combination with standard of care (SOC) of 5-fluorouracil, leucovorin, irinotecan, oxaliplatin (mFOLFIRINOX). After completing three cycles of therapy, participants with methylated-ctDNA fold change of less than threshold determined in Part 1 will continue to receive additional cycles of mFOLFIRINOX for up to 8 months. Participants with methylated-ctDNA fold-change of greater than threshold determined in Part 1 may switch to Part 2 Arm B. Total participation duration is approximately 18 months.
  • Experimental: Part 2 Arm B: Early Switch of Chemotherapy Interventional Cohort
    Participants in this group will receive ctDNA monitoring in combination with standard of care Gemcitabine and Nab-Paclitaxel therapy, after completion of up to three cycles of mFOLFIRINOX from Part 2 Arm A. Participants will receive standard of care treatment for up to 8 months. Total participation duration is approximately 18 months.

Primary Outcome Measure

Part 1:Change in ctDNA fold-change at Week 4 [ Time Frame: Baseline, Up to 4 weeks (after intervention) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Siudy Vasquez
[email protected]
(305) 243-2647
Gretel Terrero, MD (PRINCIPAL_INVESTIGATOR)

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