Adding acoustic cluster therapy to chemotherapy for locally advanced pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients with inoperable or borderline resectable locally advanced pancreatic adenocarcinoma who have not received prior pancreatic cancer treatment will receive Acoustic Cluster Therapy (an intravenous PS101 injection followed by ultrasound to the tumor) on Day 1 of each 2-week chemotherapy cycle together with modified FOLFIRINOX. Treatment can continue for up to eight 2-week cycles while investigators monitor safety and side effects at clinic visits. Tumor response and objective efficacy will be measured by CT scans every 8 weeks. The multicenter Phase 2 trial is sponsored by EXACT Therapeutics and is being conducted at three US cancer centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• HonorHealth Research Institute
  Scottsdale, Arizona, United States Recruiting
• Stanford Cancer Center Palo Alto
  Stanford, California, United States Recruiting
• Beth Israel Deaconess Medical Center - Division of Hematology/Oncology
  Boston, Massachusetts, United States Recruiting
• Henry Ford Centre
  Detroit, Michigan, United States Recruiting
• Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital
  Philadelphia, Pennsylvania, United States Recruiting
• Allegheny General Hospital
  Pittsburgh, Pennsylvania, United States Recruiting

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.