Pancreas CancerCancerProcedureDrugPhase 1
What this study is
Compare the efficacy and tolerability of IRE in combination with either FOLFIRINOX or gemcitabine in patients with locally advanced pancreatic cancer.
What's being tested
- Irreversible Electroporation (IRE)
Intervention · PROCEDURE
Non-thermal ablation of tumor
- Gemcitabine
Intervention · DRUG
- FOLFIRINOX
Intervention · DRUG
Both Gemcitabine and FOLFIRINOX
25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled
Study details
- Official title
- Chemotherapy and Irreversible Electroporation (IRE) in the Treatment of Advanced Pancreatic Adenocarcinoma
- Sponsor
- University of Louisville
- Conditions
- Pancreas Cancer
- Enrolling
- 20 people
- Starts
- 2018-05-30
- Est. completion
- 2027-07-31
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Greater than or equal to 18 years of age
- Diagnosed with stage III pancreatic cancer
- Tumor is measurable
- GFR > mL/min/1.73m2
- Willing and able to comply with protocol requirements
- AST/ALT >3 times upper limit of normal
- Stable surgical post-operative course as defined by operative surgeon
You can't join if
- Participating in another clinical trial for the treatment of cancer at the time of screening
- Pregnant or currently breast feeding
- Have a cardiac pacemaker or ICD implanted that cannot be deactivated during IRE procedure
- Have non-removable implants with metal parts within 1 cm of the target lesion
- Had a myocardial infarction within 3 months prior to enrollment
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openUniversity of Louisville
Louisville, Kentucky, United States
- Robert Martin, MD, PhD · Contact502-629-3355robert.martin@louisville.edu
- Robert Martin, MD, PhD · Principal investigator
Recruiting
Study team
Sponsor
University of Louisville
Study ID 17.0529
Principal investigator
Robert Martin, MD, PhD
University of Louisville
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.