Actively Recruiting
Utility of ctDNA in Early Switch of First-line mFOLFIRINOX in Metastatic Pancreatic Ductal Adenocarcinoma
Led by University of Miami · Updated on 2025-09-23
50
Participants Needed
1
Research Sites
263 weeks
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Utility of ctDNA in Early Switch of First-line mFOLFIRINOX in Metastatic Pancreatic Ductal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic pancreatic adenocarcinoma, including adenosquamous carcinoma and mixed adenocarcinoma/neuroendocrine carcinoma
- Treatment-nafve for metastatic pancreatic adenocarcinoma
- Detectable circulating tumor DNA (ctDNA) at cycle 1 day 1
- Detectable ctDNA on Northstar Response assay at baseline
- At least one measurable tumor lesion by CT or PET/CT scan
- Adults aged 18 years or older
- Male or non-pregnant, non-lactating female, with agreement to use contraception if of reproductive potential
- Adequate blood counts: ANC 65 1.0 �d7 10^9 cells/L; platelets 65 100,000 cells/mm3; hemoglobin 65 9 g/dL
- Adequate blood chemistry: AST/ALT 64 2.5 �d7 ULN (up to 5 �d7 ULN if liver metastases), total bilirubin 64 1.5 �d7 ULN, creatinine clearance e 60 mL/min, albumin 65 3.0 g/dL
- ECOG performance status 0 to 1
- Candidate for modified Folfirinox chemotherapy
- Consent obtained from participant or legally authorized representative if applicable
You will not qualify if you...
- Pure neuroendocrine neoplasms of the pancreas
- Brain metastases
- Uncontrolled ascites
- ECOG performance status greater than 1 between screening and enrollment
- Active uncontrolled infection requiring systemic therapy
- Untreated or uncontrolled HIV or Hepatitis B or C infection
- Uncontrolled heart disease or cardiac repolarization abnormalities, including recent myocardial infarction or cardiomyopathy
- Grade 2 or higher sensory peripheral neuropathy
- History of chronic diarrhea
- Pregnant or nursing
- Serious medical or psychiatric illness affecting safety or study data
- Participation in other interventional trials for metastatic pancreatic cancer
- Unable or unwilling to comply with study procedures
- Impaired decision-making capacity
- Any other condition that would prevent study participation per investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
S
Siudy Vasquez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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