Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source

Study Overview
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Brief Summary
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Initial study to evaluate local control and the preferred method of attachment of the CivaSheet in the setting of suspected close or positive margins at the time of surgical tumor removal.

Detailed Description
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This is a Feasibility study to determine the safety and efficacy of a new brachytherapy device that provides unidirectional radiation which utilizes active components (Palladium-103) of standard devices in a novel configuration.This pilot study may benefit pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin. The appropriate dose and local control rate will be recorded the primary endpoint in order to provide an efficacy assessment.

Official Title
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Initial Feasibility Study to Evaluate the Safety and Efficacy of the Permanently Implantable LDR CivaSheet® in Combination With External Beam Radiation in the Treatment of Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Device: Directional Brachytherapy Source Implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Dose escalation Phase I followed by a feasibility trial in Phase II
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Directional Brachytherapy Source Implant<br>Patients undergoing a pancreatic cancer resection will receive a CivaSheet LDR directional brachytherapy implant at the time of surgery. The directional nature of the FDA cleared CivaSheet is expected to allow physicians to increase the radiation dose given to the surgical margin safely, reducing risk of recurrence without increasing radiation side effects. | Device: Directional Brachytherapy Source Implant<br>* The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiaiton source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of CivaSheet Radiation Treatement | Patients will be monitored for any adverse radiation toxicity effects from the CivaSheet device. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of CivaSheet Radiation Treatment | Patients will be monitored for one year to determine the local cancer recurrence rate | 1 Year | 
| Morbidity of patients following surgery and radiation | 2 year survival rates for patients post surgery and CivaSheet radiation treatment | 2 Year | 
| Post Operative Radiation Dosimetry Calculation | Post procedure 3D treatment planning will be performed to determine if the radiation dose delivered was satisfactory | 1 Month | 
| Length of Hospital Stay | Length of hospital stay will be monitored to determine if CivaSheet radiation treatment alters the typical length of hospital stay for patients after surgery. | 1 Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CivaTech, brachytherapy, CivaSheet, whipple, radiation, borderline resectable, locally advanced, Pd-103, intraoperative radiation