Feasibility of a new brachytherapy device for treating borderline resectable 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

This study evaluates the safety and efficacy of a novel brachytherapy device, CivaSheet, designed to deliver unidirectional radiation to pancreatic cancer patients with borderline resectable tumors. The device utilizes Palladium-103 to target diseased tissue while minimizing radiation exposure to surrounding critical structures. The study aims to assess local control rates and determine the optimal method for attaching the device during surgical tumor removal. It involves patients who have undergone neoadjuvant chemoradiation and are selected for surgical procedures like the Whipple or distal pancreatectomy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* • Subject signed inform consent

  * Age \> 18 years
  * Not pregnant or breast feeding
  * Patient capable of undergoing anesthesia
  * Patient selected to undergo Whipple procedure or distal pancreatectomy
  * Patient does not have metastatic disease
  * Patients will have close margins
  * No prior radiation therapy to the region for separate cancer
  * Confirmed diagnosis of borderline resectable or locally advanced pancreatic adenocarcinoma
  * Patient Received neoadjuvant chemoradiation (4-10 weeks prior to surgery)
  * Chemotherapy was administered for 2-6 cycles with any combination of the following agents:
  * Gemcitabine + nb-paclitaxel
  * FOLFIRINOX
  * Neoadjuvant Chemoradiation was administered as IMRT or 3DCRT (up to 56 Gy), or SBRT (up to 36 Gy) with Pre-operative External beam dose (NCCN)
  * up to 56 Gy (1.8-2.0 Gy per fractions) with concurrent gemcitabine, capecitabine, or infusional 5-fluorouracil

Exclusion Criteria:

* Not surgical candidate
* Any other invasive cancer in the past 5 years, except basal cell or squamous cell skin cancer
* An IRE candidate (IRE is Percutaneous irreversible electroporation)
* Recurrent or previously resected tumors
* Documented History of Alcoholism and or drug abuse
* Participant in other clinical trials

Where it's running

• Advocate Christ Medical Center
  Oak Lawn, Illinois, United States Recruiting
• Tampa General Hospital
  Tampa, Florida, United States Not yet recruiting
• Rush University Cancer Center
  Chicago, Illinois, United States Completed
• University Medical Center LSU
  New Orleans, Louisiana, United States Completed
• Fox Chase Cancer Center
  Philadelphia, Pennsylvania, United States Completed
• Virginia Commonwealth University Massey Cancer Center
  Richmond, Virginia, United States Completed

Study contacts

• Principal investigator: Joshua Meyer, MD — Fox Chase Cancer Center
• Study coordinator: Carra Castagnero
• Email: ccastagnero@civatechoncology.com
• Phone: 919-314-5515

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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.