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New treatment option for Pancreatic Cancer
Official title Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial
ClinicalTrials.gov ID: NCT03322995
What this study is testing
What is First-line Chemotherapy?
First-line Chemotherapy 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 pancreas 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
- Be 18 years of age or older.
- Be able to understand and provide written informed consent or have a legally authorized representative (LAR).
- Have an Eastern Cooperative Group (ECOG) performance status \< 2 (please see the appendix).
- Have documentation of histologically confirmed adenocarcinoma. Biopsy must have been completed prior to start of treatment; additional biopsy is not...
- Have clinical stage consistent with resectable or borderline resectable adenocarcinoma of the pancreas, based on CT or MRI findings.
You likely can't join if
- Has received more than two months of FOLFIRINOX or mFOLFIRINOX chemotherapy as first-line therapy.
- No documentation of a CA19-9 value when total bilirubin \< 2 prior to initiation of chemotherapy.
- Has received any additional 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 human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
See the full eligibility criteria
- Be 18 years of age or older.
- Be able to understand and provide written informed consent or have a legally authorized representative (LAR).
- Have an Eastern Cooperative Group (ECOG) performance status \< 2 (please see the appendix).
- Have documentation of histologically confirmed adenocarcinoma. Biopsy must have been completed prior to start of treatment; additional biopsy is not required for the study.
- Have clinical stage consistent with resectable or 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 x10\^3/μL.
- absolute neutrophil count (ANC) \>1.5x 10\^3/μL.
- hemoglobin \>9 g/dL.
- platelets \>100 x 10\^3/μL.
- creatinine clearance \>60 mL/min or creatinine \<1.5 mg/dL; bilirubin \< 2 mg/dL.
- 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...
- people must be CA19-9 producers as defined by a pretreatment CA 19-9 \> 35 U/mL, when total bilirubin \<2 mg/dL.
- 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...
- Has received more than two months of FOLFIRINOX or mFOLFIRINOX chemotherapy as first-line therapy.
- No documentation of a CA19-9 value when total bilirubin \< 2 prior to initiation of chemotherapy.
- Has received any additional 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 human immunodeficiency virus (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
- 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 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.