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New treatment option for Pancreatic Cancer
Official title PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples
ClinicalTrials.gov ID: NCT04683315
What this study is testing
What is mFOLFIRINOX Treatment Regimen?
mFOLFIRINOX Treatment Regimen is an investigational medicine, being studied as a potential treatment for pancreatic cancer.
Also referred to as Fluorouracil, Folinic acid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, phase II study in patients with resectable and borderline resectable pancreatic cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- (for Screening)
- Have suspicion of pancreas adenocarcinoma and plan for endoscopic biopsy.
- Plan for endoscopic biopsy or agreeable to an additional EUS/FNA for research purposes, otherwise plan to obtain archival tissue for PurlST testing...
- Be 18 years of age or older.
- Be able to understand and provide written informed consent or have a legally authorized representative (LAR).
You likely can't join if
- Has received chemotherapy and/or radiation within three years prior to study enrollment.
- Has any previous history of another malignancy (other than cured basal or squamous cell carcinoma of the skin or cured in situ carcinoma of the...
- Uncontrolled comorbidities including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina...
- Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Pregnant or breastfeeding patients or any patient with childbearing potential not using contraception four weeks prior to treatment.
See the full eligibility criteria
- (for Screening)
- Have suspicion of pancreas adenocarcinoma and plan for endoscopic biopsy.
- Plan for endoscopic biopsy or agreeable to an additional EUS/FNA for research purposes, otherwise plan to obtain archival tissue for PurlST testing. (for Treatment)
- Be 18 years of age or older.
- Be able to understand and provide written informed consent or have a legally authorized representative (LAR).
- Have documentation of histologically confirmed adenocarcinoma.
- Have an Eastern Cooperative Group (ECOG) performance status \< 2.
- Have clinical stage consistent with resectable, borderline resectable adenocarcinoma of the pancreas, based on CT or MRI findings.
- Have adequate organ and bone marrow function, as defined by
- total leukocytes \>3 x103/μL.
- absolute neutrophil count (ANC) \>1.5x 103/μL.
- hemoglobin \>9 g/dL.
- platelets \>100 x 10e3/μL.
- creatinine clearance \>60 mL/min or creatinine \<1.5 mg/dL.
- bilirubin: may be enrolled with an elevated total bilirubin providing current elevated total bilirubin is shown to be in decline following a stent placement and is judged low enough to safely to begin their assigned...
- aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) \<3 x upper limit of normal (ULN). At two weeks from biliary decompression, if the subject's serum AST/ALT remains greater 3x ULN, but has...
- Female patients must be postmenopausal (absence of menses for \> 1 year), surgically sterile or have a negative pregnancy test and use at least one form of contraception for four weeks prior to Day 1 of the study...
- No evidence of extrapancreatic disease.
- No evidence of tumor-arterial abutment (celiac, SMA [superior mesenteric artery] or HA [hepatic artery]).
- If tumor-induced narrowing of the SMV [superior mesenteric vein], PV [portal vein] or SMV-PV [superior mesenteric-portal vein] confluence is present, it must be \< 50% of the diameter of the vessel.
- CA 19-9 \< 5000. Borderline Resectable PC To include at least one of the following:
- Tumor abutment \<180⁰ of the SMA or celiac axis.
- Tumor abutment or encasement (\>180⁰) of a short segment of the HA.
- \> 50% narrowing of SMV, PV or SMPV.
- Short-segment occlusion of the SMV, PV or SMV-PV with a suitable anatomy for reconstruction.
- CT or MRI findings suspicious for, but not diagnostic of, metastatic disease (based on multidisciplinary assessment).
- Radiographically suspicious or biopsy-proven N1 disease (regional lymph nodes involved) from prereferral biopsy or EUS-guided FNA.
- CA 19-9 \>5000 when bilirubin is \ 2 mg/dL and declining. Locally Advanced Type A PC To include at least one of the following:
- Between 180⁰-270⁰ encasement of SMA or
- \> 180⁰ encasement of the celiac artery without extension to aorta and amenable to celiac resection or
- \>180⁰ encasement of the hepatic artery with extension to the celiac artery and amenable to vascular reconstruction
- Has received chemotherapy and/or radiation within three years prior to study enrollment.
- Has any previous history of another malignancy (other than cured basal or squamous cell carcinoma of the skin or cured in situ carcinoma of the cervix or localized prostate cancer with normal prostate specific antigen)...
- Uncontrolled comorbidities including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina, unstable cardiac arrhythmias, psychiatric illness, excessive obesity...
- Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Pregnant or breastfeeding patients or any patient with childbearing potential not using contraception four weeks prior to treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.