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

Study Overview
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Brief Summary
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This is a Phase I evaluation to determine the usefulness of a new brachytherapy device that utilizes active components (Palladium-103) of standard devices in a novel configuration. This study may benefit resectable 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.

Official Title
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Initial Feasibility Study to Treat Resectable Pancreatic Cancer With the Permanently Implantable LDR CivaSheet®

Conditions
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Pancreas Cancer, Cancer

Intervention / Treatment
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* Device: CivaSheet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject signed informed consent Age >/= 18 years Biopsy confirmed adenocarcinoma pancreatic cancer Patient capable of undergoing anesthesia Patient is a surgical candidate Patient selected to undergo pancreatic cancer resection Patient will have known or suspected close/positive surgical margin Confirmed diagnosis of resectable pancreatic adenocarcinoma Will be prescribed standard Gemcitabine 1000 mg/m2 chemotherapy cycle Exclusion Criteria: Pregnant or breast feeding Patient has metastatic disease Patient has had prior radiation therapy to the region for separate cancer Patient has had prior chemotherapy Any other invasive cancer in the past 5 years, except basal cell skin Recurrent or previously resected tumors Alcoholism/Drug abuse

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Directional Brachytherapy Source Implant<br>Patients undergoing a whipple procedure for pancreatic cancer will receive an implant at the time of surgery of the new CivaSheet directional brachytherapy device. 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: CivaSheet<br>* The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiation 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 & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale | Patients with resectable pancreatic cancer who are undergoing pancreatic cancer resection will be monitored for safety & toxicities graded using the CTCAE 4.0 scale. | 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Whipple, brachytherapy, CivaSheet, CivaTech Oncology, radiation, intraoperative radiation, IORT, resectable pancreatic cancer, Pd-103