RECRUITINGPhase 2INTERVENTIONAL
Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer
A Phase 2 Study to Investigate the Efficacy and Safety of Acoustic Cluster Therapy With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer
About This Trial
The purpose of the study is to assess the efficacy and safety of Acoustic Cluster Therapy (ACT) when given in addition to chemotherapy for treatment of Locally Advanced Pancreatic Cancer.
Who May Be Eligible (Plain English)
Who May Qualify:
- Not deemed suitable for primary curative surgery and have radiographic and pathological disease consistent with inoperable LAPC or borderline resectable pancreatic cancer.
- Suitable to receive treatment with mFOLFIRINOX according to the Investigator's assessment.
Who Should NOT Join This Trial:
• Any prior anti-cancer treatment for pancreatic cancer (e.g. chemotherapy, surgery, radiation). Palliative bypass procedure and bile duct stenting are allowed.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Not deemed suitable for primary curative surgery and have radiographic and pathological disease consistent with inoperable LAPC or borderline resectable pancreatic cancer.
* Suitable to receive treatment with mFOLFIRINOX according to the Investigator's assessment.
Exclusion Criteria:
• Any prior anti-cancer treatment for pancreatic cancer (e.g. chemotherapy, surgery, radiation). Palliative bypass procedure and bile duct stenting are allowed.
Treatments Being Tested
COMBINATION_PRODUCT
Acoustic Cluster Therapy
Drug: PS101; Device: Ultrasound
DRUG
Modified FOLFIRINOX
Chemotherapy
Locations (10)
HonorHealth Research Institute
Scottsdale, Arizona, United States
Stanford Cancer Center Palo Alto
Stanford, California, United States
Beth Israel Deaconess Medical Center - Division of Hematology/Oncology
Boston, Massachusetts, United States
Henry Ford Centre
Detroit, Michigan, United States
Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Brown University Cancer Institute
Providence, Rhode Island, United States
CAMBRIDGE CANCER TRIALS CENTRE-Addenbrooke's Hospital
Cambridge, Cambridge, United Kingdom
Gary Weston Centre- Imperial College Healthcare- Du Cane Road
Hammersmith, London, United Kingdom
The Royal Marsden- Downs Road
Sutton, Surrey, United Kingdom