Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Patients with Locally Advanced Pancreatic Cancer who have not received prior treatment to their pancreatic cancer will receive ACT treatment (the drug PS101 and ultrasound application to the tumor) with up to eight 2-week cycles of modified FOLFIRINOX chemotherapy.
ACT treatment will be given on Day 1 of each cycle of chemotherapy. Patients' well-being and side effects will be assessed at the same visits. The objective efficacy of the treatment will be assessed by CT scans every 8 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acoustic Cluster Therapy (ACT) with mFOLFIRINOX | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acoustic Cluster Therapy | Combination Product | Drug: PS101; Device: Ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR (Overall response rate), defined as the number of participants with measurable disease at baseline who have a confirmed Complete Response or confirmed Partial Response according to RECIST Version 1.1. | From baseline to end of treatment (up to Week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall summary of TEAEs including number and percentage of participants with at least one TEAE. TEAEs will be summarized by System Organ Class and Preferred Term. TEAEs will be summarized by severity and causality. | From enrollment up to week 24 | |
| Change in maximum tumor diameter and volume summarized as the largest or the smallest percentage change from baseline. Independent central image review based on RECIST 1.1 criteria will be the primary analysis. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
• Any prior anti-cancer treatment for pancreatic cancer (e.g. chemotherapy, surgery, radiation). Palliative bypass procedure and bile duct stenting are allowed.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Recruiting | Scottsdale | Arizona | 85258 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Modified FOLFIRINOX | Drug | Chemotherapy |
|
| From baseline up to week 24 |
| Median OS and proportion of participants alive at 6 months. | from baseline to week 24 |
| The proportion of participants becoming eligible for resection as determined by local multidisciplinary team review | from baseline to week 24 |
| Stanford Cancer Center Palo Alto | Recruiting | Stanford | California | 94305 | United States |
|
| Beth Israel Deaconess Medical Center - Division of Hematology/Oncology | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| Henry Ford Centre | Recruiting | Detroit | Michigan | 48202 | United States |
|
| Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|
| Allegheny General Hospital | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
|
| Brown University Cancer Institute | Recruiting | Providence | Rhode Island | 02906 | United States |
|
| CAMBRIDGE CANCER TRIALS CENTRE-Addenbrooke's Hospital | Recruiting | Cambridge | Cambridge | CB2 0QQ | United Kingdom |
|
| Gary Weston Centre- Imperial College Healthcare- Du Cane Road | Recruiting | Hammersmith | London | W12 0HS | United Kingdom |
|
| The Royal Marsden- Downs Road | Recruiting | Sutton | Surrey | SM2 5PT | United Kingdom |
|
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D021441 | Carcinoma, Pancreatic Ductal |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D044584 | Carcinoma, Ductal |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
Not provided
Not provided