Initial Feasibility Study To Treat Borderline Resectable Pancreatic Cancer With A Planar LDR Source

Study Overview

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

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.

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.

Pancreatic Cancer

DEVICE: Directional Brachytherapy Source Implant

CT004

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-06-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-02
First Submitted that Met QC Criteria 2016-07-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-04
First Posted (ACTUAL) 2016-07-26	Results First Posted N/A	Last Verified 2024-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Directional Brachytherapy Source Implant 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 giv	DEVICE: Directional Brachytherapy Source Implant 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 ta

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Directional Brachytherapy Source Implant

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 giv

DEVICE: Directional Brachytherapy Source Implant

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 ta

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Carra Castagnero

Phone Number: 919-314-5515

Email: ccastagnero@civatechoncology.com

Study Contact Backup

Name: Kristy Perez, PhD

Phone Number: 9193145515

Email: kperez@civatechoncology.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

• 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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Joshua Meyer, MD, Fox Chase Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record